RO.SW - Roche Holding AG

Swiss - Swiss Delayed price. Currency in CHF
271.00
+3.60 (+1.35%)
At close: 5:30PM CEST
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Previous close267.40
Open268.20
Bid284.20 x 0
Ask257.40 x 0
Day's range268.20 - 271.40
52-week range229.20 - 283.00
Volume40,346
Avg. volume27,708
Market cap233.086B
Beta (3Y monthly)1.06
PE ratio (TTM)19.78
EPS (TTM)13.70
Earnings date25 Jul 2019 - 25 Jul 2019
Forward dividend & yield8.70 (3.25%)
Ex-dividend date2019-03-07
1y target est281.00
  • Business Wire

    FDA Approves Genentech’s Rozlytrek (entrectinib) for People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors

    OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

  • Business Wire

    Genentech’s Tecentriq® (ATEZOLIZUMAB) Plus Platinum-based Chemotherapy Reduced the Risk of Disease Worsening or Death in People With Previously Untreated Advanced Bladder Cancer

    The combination of Tecentriq® (atezolizumab) plus platinum-based chemotherapy showed a statistically significant reduction in the risk of disease worsening or death in people with previously untreated locally advanced or metastatic urothelial carcinoma (mUC) compared with chemotherapy alone. Safety in the Tecentriq plus chemotherapy arm appeared consistent with the known safety profiles of the individual medicines and no new safety signals were identified with the combination. “IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer, an aggressive disease with high unmet need,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development.

  • Business Wire

    Genentech Presents a Broad Range of Data for Hemlibra (Emicizumab-kxwh) Demonstrating Continued Benefits for People With Hemophilia A at the ISTH 2019 Congress

    OTCQX: RHHBY), announced today new data for Hemlibra® (emicizumab-kxwh) across multiple pivotal studies in people with hemophilia A with and without factor VIII inhibitors at the International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress on July 6-10 in Melbourne, Australia. In total, Genentech presented 21 abstracts from its hemophilia program, including five oral presentations.

  • Reuters

    Roche, Spark push back takeover deadline in $4.3 billion deal

    Roche and Spark Therapeutics agreed to extend the deadline for the Swiss drugmaker's $4.3 billion takeover bid for the U.S. gene therapy specialist, Roche said, adding it remains "fully committed" to a deal it sees closing this year. The new deadline for both companies to extend the merger agreement is now April 30, 2020, rather than Jan. 31, 2020, Roche said in a U.S. regulatory filing on Monday, saying the change provides "additional time to clear the transaction". Roche's March 5 bid to add Spark's gene therapy technology is dragging on, with completion pushed back several times as the Swiss company blames time-consuming U.S. Federal Trade Commission scrutiny of any competition issues.

  • Business Wire

    Genentech Announces Positive Results for First Global Phase III Study Investigating One-dose XOFLUZA (Baloxavir Marboxil) in Children With the Flu

    OTCQX: RHHBY), today announced that the Phase III MINISTONE-2 study met its primary endpoint, demonstrating that XOFLUZA™ (baloxavir marboxil) was well-tolerated in children with the flu. The study also showed that XOFLUZA is comparable to oseltamivir – a proven effective treatment for children with the flu – at reducing the duration of flu symptoms, including fever.

  • Business Wire

    Phase III PEMPHIX Study Showed That Genentech’s Rituxan (Rituximab) is Superior to Standard of Care in Achieving Sustained Remission in Patients with Pemphigus Vulgaris

    OTCQX: RHHBY), today announced positive top line results from the Roche-sponsored Phase III PEMPHIX study evaluating the efficacy and safety of Rituxan® (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV). The study met the primary endpoint, and demonstrated that Rituxan is superior to MMF in achieving sustained complete remission.

  • Business Wire

    FDA Grants Priority Review to Genentech’s Rituxan (Rituximab) in Children with Two Rare Blood Vessel Disorders

    SOUTH SAN FRANCISCO, Calif.-- -- There are currently no FDA approved treatments for children living with granulomatosis with polyangiitis or microscopic polyangiitis The PePRS study is the first global trial of Rituxan in pediatric patients with GPA or MPA Rituxan in combination with glucocorticoids is the only FDA-approved therapy for adults with these two rare forms of vasculitis If approved, this ...

  • Business Wire

    Genentech’s Gazyva (Obinutuzumab) Delivers Positive Topline Results for Phase II Lupus Nephritis Study

    OTCQX: RHHBY), today announced positive topline results for NOBILITY, a Phase II clinical trial investigating the safety and efficacy of Gazyva® (obinutuzumab) for adults with proliferative lupus nephritis. The study met its primary endpoint, showing Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrated enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year. In addition, Gazyva met key secondary endpoints showing improved overall renal responses (complete and partial renal response) and serologic markers of disease activity as compared to placebo.

  • Business Wire

    FDA Grants Genentech’s Polivy Accelerated Approval for People with Previously Treated Aggressive Lymphoma

    OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. Accelerated approval was granted for this indication based on complete response rates observed in a randomized, controlled clinical trial.

  • Globe Newswire

    Pivotal phase III CLL14 results for Venclexta/Venclyxto in combination with Gazyva/Gazyvaro for chronic lymphocytic leukaemia presented at ASCO 2019 and published in the New England Journal of Medicine

    Pivotal phase III CLL14 results for Venclexta/Venclyxto in combination with Gazyva/Gazyvaro for chronic lymphocytic leukaemia presented at ASCO 2019 and published in the New England Journal of Medicine * Venclexta/Venclyxto plus Gazyva/Gazyvaro showed improvements across multiple efficacy measures compared to Gazyva/Gazyvaro plus chlorambucil, including progression-free survival and deep remissions as determined by minimal residual disease measurement * This 12-month, fixed-duration, chemotherapy-free combination was recently approved for previously untreated chronic lymphocytic leukaemia under the FDA’s Real-Time Oncology Review pilot programme Basel, 4 June 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the pivotal phase III CLL14 study in previously untreated chronic lymphocytic leukaemia (CLL) showing that Venclexta®/Venclyxto® (venetoclax) plus Gazyva®/Gazyvaro® (obinutuzumab) met its primary endpoint of investigator-assessed progression-free survival (PFS). The 12-month, fixed-duration, chemotherapy-free combination reduced the risk of disease worsening or death by 65% compared to Gazyva/Gazyvaro plus chlorambucil (PFS, as assessed by investigator; HR=0.35; 95% CI 0.23-0.53; p<0.001), when given to people with previously untreated CLL who have co-existing medical conditions. The results were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM).1,2 At two years, one year after stopping treatment, nearly nine out of ten patients (88.2%) in the Venclexta/Venclyxto plus Gazyva/Gazyvaro arm remained progression-free, compared to 64.1% in the Gazyva/Gazyvaro plus chlorambucil arm. Safety for Venclexta/Venclyxto plus Gazyva/Gazyvaro appeared consistent with the known safety profiles of the individual medicines. Common Grade 3-4 adverse events with Venclexta/Venclyxto plus Gazyva/Gazyvaro compared to Gazyva/Gazyvaro plus chlorambucil, respectively, were low white blood cell count (52.8% vs. 48.1%) and infections (17.5% vs. 15.0%). “The results of our phase III CLL14 trial, reported today at ASCO and in the New England Journal of Medicine, represent a major advance in improving outcomes in chronic lymphocytic leukaemia,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased this fixed-duration, chemotherapy-free regimen of Venclexta/Venclyxto plus Gazyva/Gazyvaro was approved by the FDA and look forward to providing an important treatment option to even more adults with the most common form of adult leukaemia.” The treatment benefit demonstrated with the Venclexta/Venclyxto plus Gazyva/Gazyvaro combination compared to Gazyva/Gazyvaro plus chlorambucil was consistent across secondary endpoints, including: * Overall response (84.7% vs. 71.3%; p<0.001). * Complete response with at least partial blood count recovery (49.5% vs. 23.1%; p<0.001). * Minimal residual disease (MRD)-negativity in the bone marrow (56.9% vs. 17.1%; p<0.001) and peripheral blood (75.5% vs. 35.2%; p<0.001) three months after treatment. MRD-negativity means no cancer can be detected using a specific, highly sensitive test, and was defined as less than one CLL cell in 10,000 white blood cells.These data were presented at the 2019 ASCO Annual Meeting on Tuesday 4 June 2019, at 10.09-10.21 CST (17.09-17.21, CET; abstract 7502), and simultaneously published in the NEJM. The US Food and Drug Administration (FDA) approved the combination on 15 May 2019, under the FDA’s Real-Time Oncology Review and Assessment Aid pilot programmes, for the treatment of people with previously untreated CLL or small lymphocytic lymphoma. This is the second regimen of Roche medicines approved under the RTOR pilot programme, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. Additional submissions of the CLL14 data to health authorities around the world are ongoing. Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US and commercialised by AbbVie outside of the US. About the CLL14 study 2 CLL14 (NCT02242942) is a randomised phase III study evaluating the combination of fixed-duration Venclexta/Venclyxto plus Gazyva/Gazyvaro compared to Gazyva/Gazyvaro plus chlorambucil in patients with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions. Co-existing medical conditions included reduced kidney function or co-morbidities assessed by a standard scale (Cumulative Illness Rating Scale). 432 patients with previously untreated CLL were randomly assigned to receive either a 12-month duration of Venclexta/Venclyxto alongside six-month duration of Gazyva/Gazyvaro (Arm A) or six-month duration of Gazyva/Gazyvaro alongside 12-month duration of chlorambucil (Arm B). Arm A started with an initial dosing of Gazyva/Gazyvaro followed by a five-week Venclexta/Venclyxto dose ramp-up to help reduce the risk of tumour lysis syndrome. The primary endpoint of the study is investigator-assessed progression-free survival (PFS). Secondary endpoints include PFS assessed by independent review committee (IRC), minimal residual disease (MRD) status, overall response rate (ORR), complete response (with or without complete blood count recovery), overall survival, duration of response, event-free survival, time to next CLL treatment, and safety. The CLL14 study is being conducted in cooperation with the German CLL Study Group, headed by Michael Hallek, MD, University of Cologne. After a median follow-up of 28 months, results showed: * Patients who received Venclexta/Venclyxto plus Gazyva/Gazyvaro lived significantly longer without their disease worsening (PFS, as assessed by investigator) compared to those who received Gazyva/Gazyvaro plus chlorambucil (HR 0.35; 95% CI 0.23-0.53; p<0.001). * At two years, 88.2% of patients in the Venclexta/Venclyxto plus Gazyva/Gazyvaro arm had not experienced disease progression, compared to 64.1% with Gazyva/Gazyvaro plus chlorambucil.     * Median PFS reported by investigators was not yet reached in either arm. IRC assessment of PFS was consistent (HR 0.33; 95% CI, 0.22- 0.51; p<0.001). * Clinical benefit observed for Venclexta/Venclyxto plus Gazyva/Gazyvaro compared to Gazyva/Gazyvaro plus chlorambucil was consistent across secondary endpoints, including ORR (84.7% vs. 71.3%; p<0.001) and CR including incomplete marrow recovery (49.5% vs. 23.1%; p<0.001). * In addition, higher rates of MRD-negativity in the bone marrow (56.9% vs. 17.1%; p<0.001) and peripheral blood (75.5% vs. 35.2%; p<0.001) were observed three months after treatment with Venclexta/Venclyxto plus Gazyva/Gazyvaro compared to Gazyva/Gazyvaro plus chlorambucil. MRD-negativity was defined as less than one CLL cell in 10,000 leukocytes. * Safety for Venclexta/Venclyxto plus Gazyva/Gazyvaro appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. Common Grade 3-4 adverse events with Venclexta/Venclyxto plus Gazyva/Gazyvaro compared to Gazyva/Gazyvaro plus chlorambucil, respectively, were low white blood cell count (52.8% vs. 48.1%) and infections (17.5% vs. 15.0%). About Venclexta/Venclyxto (venetoclax) Venclexta/Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta/Venclyxto blocks the BCL-2 protein and works to restore the process of apoptosis. Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US and by AbbVie outside of the US. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being studied in clinical trials across several types of blood and other cancers. In the US, Venclexta has been granted five Breakthrough Therapy Designations by the Food and Drug Administration (FDA): in combination with Rituxan for people with relapsed or refractory chronic lymphocytic leukaemia (CLL); as a monotherapy for people with relapsed or refractory CLL with 17p deletion; in combination with hypomethylating agents (azacitidine or decitabine) for people with untreated acute myeloid leukaemia (AML) ineligible for intensive chemotherapy; in combination with low-dose cytarabine (LDAC) for people with untreated AML ineligible for intensive chemotherapy, and in combination with Gazyva in people with previously untreated CLL and co-existing medical conditions. Venclexta/Venclyxto is approved in more than 50 countries. Roche and AbbVie are currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need. About Gazyva/Gazyvaro (obinutuzumab) Gazyva/Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on certain B-cells, but not on stem cells or plasma cells. Gazyva/Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body's immune system. Gazyva is marketed as Gazyvaro in the EU and Switzerland. Gazyva/Gazyvaro is currently approved in more than 90 countries in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia, in more than 80 countries in combination with bendamustine for people with certain types of previously treated follicular lymphoma and in more than 70 countries in combination with chemotherapy for previously untreated follicular lymphoma. Additional combination studies investigating Gazyva/Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers. About the German CLL Study Group (GCLLSG) Founded in 1996 and headed by Michael Hallek, MD, the GCLLSG has been running various phase III, phase II and phase I trials in chronic lymphocytic leukaemia (CLL) with the goal to provide optimal treatment to patients suffering from this disease. Among those were landmark trials like the CLL8 and the CLL11 trials which led to the current standard of care in CLL. For many years, GCLLSG has been aiming to improve not just the treatment of younger and physically fit patients, but also that of elderly and less fit patients. These patients are generally underrepresented in clinical trials although they constitute the majority of CLL patients treated by doctors in daily practice. The GCLLSG is an independent non-profit research organisation supported by the German Cancer Aid (Deutsche Krebshilfe). www.dcllsg.de About Roche in haematology Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, and Hemlibra® (emicizumab). Our pipeline of investigational haematology medicines includes polatuzumab vedotin, an anti-CD79b antibody drug conjugate; idasanutlin, a small molecule which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies targeting both CD20 and CD3, and Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] Fischer K, et al. Fixed-duration venetoclax plus obinutuzumab (VenG) improves progression-free survival (PFS), and rates and duration of minimal residual disease negativity (MRD–) in previously untreated patients (pts) with chronic lymphocytic leukemia (CLL) and comorbidities. Presented at: ASCO Annual Meeting; 2019 May 31-Jun 4; Chicago, IL, USA. Abstract 7502. [2] Fischer K, et al. Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. N Engl J Med. 2019; DOI: 10.1056/NEJMoa1815281 Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com \- Nicolas Dunant (Head) \- Patrick Barth \- Ulrike Engels-Lange \- Simone Oeschger \- Anja von Treskow  Attachment * 190604_ASCO_MR_CLL14_EN

  • Business Wire

    Pivotal Phase III CLL14 Results for Venclexta in Combination with Gazyva for Chronic Lymphocytic Leukemia Presented at ASCO 2019 and Published in the New England Journal of Medicine

    OTCQX: RHHBY), today announced results from the pivotal Phase III CLL14 study in previously untreated chronic lymphocytic leukemia (CLL) showing that Venclexta® (venetoclax) plus Gazyva® (obinutuzumab) met its primary endpoint of investigator-assessed progression-free survival (PFS).

  • Business Wire

    Phase III Study Showed XOFLUZA (Baloxavir Marboxil) is Effective at Preventing Influenza Infection

    OTCQX: RHHBY), today announced that the Phase III BLOCKSTONE study, conducted by Shionogi & Co., Ltd., met its primary endpoint showing that people exposed to a household member with influenza (flu) and treated preventatively with XOFLUZA™ (baloxavir marboxil) were significantly less likely to develop the disease compared to those treated with placebo (1.9% versus 13.6%, p

  • Globe Newswire

    Roche presents data from across its breast cancer portfolio at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting

    Roche presents data from across its breast cancer portfolio at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting * Roche data from 17 breast cancer abstracts presented at this year’s meeting * An overall survival improvement was observed with Tecentriq and nab-paclitaxel in PD-L1-positive metastatic triple-negative breast cancer at the second interim analysis * End-of-study results in phase III CLEOPATRA study showed over a third (37%) of metastatic HER2-positive breast cancer patients in the Perjeta arm were alive at eight years Basel, 3 June 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presents new and updated results from a number of abstracts highlighting studies including the treatment of both PD-L1-positive triple-negative and HER2-positive breast cancer at the 2019 ASCO Annual Meeting, 31 May – 4 June, in Chicago, United States. Data include results from the second overall survival (OS) interim analysis from the phase III IMpassion130 study evaluating Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the initial (first-line) treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).1 In HER2-positive breast cancer, results of an end-of-study analysis of the phase III CLEOPATRA study will also be presented, evaluating the long-term efficacy and safety of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and docetaxel chemotherapy (the Perjeta-based regimen) in patients with previously untreated HER2-positive metastatic breast cancer (mBC).2 “Our science-driven approach has been transforming standards of care in breast cancer for more than 20 years, and we are excited to present data from a Perjeta study, that showed an unprecedented survival benefit for patients living with advanced HER2-positive disease,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are continuing our transformative work in breast cancer, presenting updated interim overall survival results from our phase III Tecentriq combination, the first positive immunotherapy study in PD-L1-positive metastatic triple-negative breast cancer, a disease with high unmet need.” TNBC is a form of breast cancer representing approximately 15% of all cases.3,4 Metastatic TNBC is one of the most aggressive and difficult-to-treat forms of breast cancer.3,4 HER2-positive disease is another particularly aggressive form of breast cancer accounting for approximately 15-20% of all cases of breast cancer. 5 IMpassion130 study results Results presented at ASCO were consistent with the first interim analysis reported at the European Society for Medical Oncology congress in October 2018.1,6 At the second interim analysis, statistical significance was not met for overall survival (OS) in the intention-to-treat (ITT) population (median OS=21.0 vs 18.7 months; HR=0.86, 95% CI: 0.72-1.02, p=0.078).1 However, Tecentriq and nab-paclitaxel showed a clinically meaningful OS improvement of seven months vs placebo and nab-paclitaxel in patients who were tested positively for PD-L1 expression on tumour-infiltrating immune cells (median OS=25.0 vs 18.0 months; HR=0.71, 95% CI: 0.54-0.93) with more mature data.1 OS results in the PD-L1-positive population were not formally tested due to the prespecified hierarchical analysis plan of the study. Over half (51% (43-59%)) of PD-L1-positive metastatic TNBC patients in the Tecentriq arm were alive at two years, compared with 37% (29-45%) in the control arm. Follow-up will continue until the next planned analysis.1 Additional analyses of patient-reported outcomes from IMpassion130 showed that the combination was well-tolerated, similarly to nab-paclitaxel alone.7 Tecentriq plus nab-paclitaxel showed gains in clinical benefit without compromising patients health-related quality of life (HRQoL), day-to-day functioning and without increasing patients toxicity burden compared to nab-paclitaxel alone.7 HRQoL evaluates the overall impact of disease and treatment on patient’s quality of life in terms of disease related symptoms, treatment side effects and function/well-being. An expanded safety analysis showed that the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles from the primary data with no new safety signals observed.8 CLEOPATRA study results After a follow-up of eight years, results from the phase III CLEOPATRA study, investigating patients with previously untreated HER2-positive mBC, showed a median OS benefit of 57.1 months in the Perjeta arm compared with 40.8 months in the control arm (placebo, Herceptin and chemotherapy), an absolute improvement of 16.3 months, with a 31% overall reduction in the risk of death (HR=0.69, 95% CI 0.58-0.82, p<0.0001).2 These new data are consistent with previously published results and confirm that the unprecedented OS benefit of the Perjeta-based regimen was maintained after an additional four years of follow-up.2 Significantly, over a third (37%) of HER2-positive mBC patients in the Perjeta arm were alive at eight years, compared with 23% in the control arm.2 Safety data from the long-term follow-up study were consistent, and showed that the cardiac and overall safety profiles of the Perjeta-based regimen were maintained.2 Additionally, data from the Chinese phase III PUFFIN study were presented at this year’s meeting further confirming the use of the Perjeta-based regimen in HER2-positive mBC, as results were consistent with those seen in the CLEOPATRA study.9 Roche’s breadth of expertise continues to advance breast cancer research with the goal of expanding treatment options to improve the lives of patients living with the disease worldwide. About the IMpassion130 study The IMpassion130 study is a phase III, multicentre, randomised, double-blind study evaluating the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel compared with placebo plus nab-paclitaxel in people with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for mBC. The study enrolled 902 people who were randomised equally (1:1). The co-primary endpoints are progression-free survival (PFS) per investigator assessment (RECIST 1.1) in the ITT population and in the PD-L1-positive population and OS in the ITT population. Secondary endpoints include objective response rate and duration of response. About the CLEOPATRA Study CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) was an international, phase III, randomised, double-blind, placebo-controlled study. The study compared the combination of Perjeta, Herceptin and docetaxel chemotherapy with placebo, Herceptin and chemotherapy in 808 people with previously untreated HER2-positive mBC, or with HER2-positive mBC that had come back after prior therapy in the adjuvant or neoadjuvant setting. The primary endpoint of the study was PFS as assessed by an independent review committee. Secondary endpoints included OS and safety profile. About Roche in breast cancer Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive. Our targeted medicines Herceptin, Perjeta and Kadcyla are continuing to transform the treatment of early and advanced HER2-positive breast cancer and, through our Tecentriq and ipatasertib clinical programmes, we are committed to bring new treatment combinations to people with triple-negative breast cancer, ultimately improving outcomes. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] Schmid P, et al. IMpassion130: updated overall survival (OS) from a global, randomized, double- blind, placebo-controlled, phase III study of atezolizumab (atezo) + nab-paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC). Presented at: ASCO Annual Meeting; 2019 May 31-Jun 4; Chicago, IL, USA. Abstract 1003. [2] Swain S, et al. End-of-study analysis from the phase III, randomized, double-blind, placebo (Pla)-controlled CLEOPATRA study of first-line (1L) pertuzumab (P), trastuzumab (H), and docetaxel (D) in patients (pts) with HER2-positive metastatic breast cancer (MBC). Presented at: ASCO Annual Meeting; 2019 May 31-Jun 4; Chicago, IL, USA. Abstract 1020. [3] Yao H, et al. Oncotarget. 2017;8(1):1913-1924. [4] Breastcancer.org. What is Triple-Negative Breast Cancer? [Internet; cited 2019 May 17]. Available from: https://www.breastcancer.org/symptoms/diagnosis/trip_neg?what. [5] Wolff AC, et al. J Clin Oncol. 2013;31(31):3997-4013. [6] Schmid P, et al. N Engl J Med. 2018;379:2108-2121. [7] Adams S, et al. Patient-reported outcomes (PROs) from the phase III IMpassion130 trial of atezolizumab (atezo) plus nab-paclitaxel (nP) in metastatic triple-negative breast cancer (mTNBC). Presented at: ASCO Annual Meeting; 2019 May 31-Jun 4; Chicago, IL, USA. Abstract 1067. [8] Schneeweiss A, et al. IMpassion130: expanded safety analysis from a P3 study of atezolizumab (A) + nab-paclitaxel (nP) in patients (pts) with treatment (tx)-naïve, locally advanced or metastatic triple-negative breast cancer (mTNBC). Presented at: ASCO Annual Meeting; 2019 May 31-Jun 4; Chicago, IL, USA. Abstract 1068. [9] Binghe X, et al. A phase III, randomized, double-blind, placebo (Pla)-controlled study of pertuzumab (P) + trastuzumab (H) + docetaxel (D) v Pla + H+ D in previously untreated HER2-positive locally recurrent/metastatic breast cancer (LR/MBC) (PUFFIN). Presented at: ASCO Annual Meeting; 2019 May 31-Jun 4; Chicago, IL, USA. Abstract 1067. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com \- Nicolas Dunant (Head) \- Patrick Barth \- Ulrike Engels-Lange \- Simone Oeschger \- Anja von TreskowAttachment * 190603_MR_ASCO_Breast Cancer_ Final_EN

  • Business Wire

    Xolair (Omalizumab) Significantly Reduced Nasal Polyps and Congestion Symptoms in Adults with Chronic Rhinosinusitis with Nasal Polyps in Two Phase III Studies

    OTCQX: RHHBY), today announced positive topline data from two Phase III multicenter studies evaluating Xolair® (omalizumab) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have not adequately responded to intranasal corticosteroids. The POLYP 1 and POLYP 2 Phase III trials met both co-primary endpoints and key secondary endpoints.

  • Globe Newswire

    Roche’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer shows positive data in those with liver metastases

    Roche’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer shows positive data in those with liver metastases * Data will be presented at the American Society of Clinical Oncology (ASCO) annual meeting on 2 June 2019 Basel, 2 June 2019 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive additional results of a prespecified exploratory analysis from the Phase III IMpower150 study, which demonstrated that the combination of Tecentriq® (atezolizumab), Avastin® (bevacizumab), carboplatin and paclitaxel (chemotherapy) gave patients with chemotherapy-naïve, metastatic non-squamous non-small cell lung cancer (NSCLC), with baseline liver metastases an overall survival (OS) advantage compared with the combination of Avastin and chemotherapy (median OS=13.3 vs 9.4 months; hazard ratio [HR]=0.52; 95% CI: 0.33–0.82) in the intention-to-treat (ITT) population.1 Safety for the Tecentriq, Avastin, and chemotherapy combination appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. “We are pleased to present further positive results from the Phase III IMpower150 study that show benefit in people with baseline liver metastases, a population with a worse prognosis for survival”, said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Initial treatment with Tecentriq, Avastin and chemotherapy may represent an important new option for people with baseline liver metastases, as their risk of death was reduced by nearly half and 60% responded to the combination treatment”. These data will be presented at the American Society of Clinical Oncology (ASCO) annual meeting on Sunday, 2 June 2019 at 16:30–18:00 CDT (Abstract 9012). In December 2018, the US Food and Drug Administration approved Tecentriq in combination with Avastin, carboplatin and paclitaxel for the first-line treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations. This approval was based on positive data from Arm B of the Phase III IMpower150 study, which showed that Tecentriq and Avastin plus carboplatin and paclitaxel helped people live significantly longer compared with Avastin plus carboplatin and paclitaxel (median OS=19.2 vs 14.7 months; HR=0.78; p=0.016) in the intention-to-treat wild-type (ITT-WT) population.2 In March 2019, the European Commission also approved and granted marketing authorisation for Tecentriq in combination with Avastin, paclitaxel and carboplatin for the first-line treatment of adults with metastatic non-squamous NSCLC. In people with EGFR-mutant or ALK-positive NSCLC, Tecentriq, in combination with Avastin, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies. This approval was based on positive data from Arm B of the Phase III IMpower150 study, which showed that Tecentriq and Avastin plus carboplatin and paclitaxel helped people live significantly longer compared with Avastin plus carboplatin and paclitaxel (median OS=19.8 vs 14.9 months; HR=0.76; 95% CI: 0.63–0.96; p=0.006) in the ITT population.3 About the IMpower150 study IMpower150 is a multicentre, open-label, randomised, controlled Phase III study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and paclitaxel) with or without Avastin in people with stage IV or recurrent metastatic non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. A total of 1,202 people were enrolled, of whom 1,045 were in the ITT-WT subpopulation, which excluded those people with EGFR and ALK mutations. People were randomised (1:1:1) to receive: * Tecentriq plus carboplatin and paclitaxel (Arm A), or * Tecentriq and Avastin plus carboplatin and paclitaxel (Arm B), or * Avastin plus carboplatin and paclitaxel (Arm C, control arm). The co-primary endpoints comparing Arms B and C were OS and progression-free survival (PFS), as determined by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) and assessed in the ITT-WT subpopulation. Key secondary endpoints included investigator-assessed PFS, OS and safety in the ITT population. Exploratory analyses included efficacy and safety in people with baseline liver metastases. A summary of the ITT data for the liver metastases population (a prespecified exploratory subgroup) from the IMpower150 study is included below:1 * A survival advantage was observed in people who received Tecentriq in combination with Avastin and chemotherapy, compared with Avastin and chemotherapy alone (median OS=13.3 vs 9.4 months; HR=0.52; 95% CI: 0.33–0.82). * In addition, Tecentriq, Avastin and chemotherapy reduced the risk of disease worsening or death (PFS) by 59%, compared with Avastin and chemotherapy (HR=0.41; 95% CI: 0.26–0.62). * Tecentriq, Avastin and chemotherapy shrank tumours (overall response rate) in 60.8% of people (95% CI: -0.75–40.18) compared with 41.1% of people receiving Avastin and chemotherapy. * The median duration of response for people receiving Tecentriq, Avastin and chemotherapy was 10.7 months (95% CI: 0.21–0.73) compared with 4.6 months for people on Avastin and chemotherapy. * Grade 3–4 treatment-related adverse events occurred in 52.1% and 54.5% of patients with liver metastases in Arm B and Arm C, respectively. About NSCLC Lung cancer is the leading cause of cancer death globally.4 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.4 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.5 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.5 Typically, 15–20% of NSCLC cases will also present with liver metastasis, which are difficult-to-treat; these patients have a poorer prognosis, with an approximately 50% increased risk of death.6 In addition, patients with liver metastases are more likely to have other metastases in the body.7 About Tecentriq Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. In the United States, Tecentriq in combination with nab-paclitaxel is approved for treatment of PD-L1-positive metastatic triple-negative breast cancer; and in combination with Avastin and chemotherapy for the initial treatment of people with metastatic non-squamous NSCLC. Tecentriq is also approved in the United States as an initial treatment for extensive-stage small cell lung cancer (ES-SCLC). In the Europe Union, the non-squamous NSCLC indication includes people with EGFR mutant or ALK genomic tumour aberrations after failure of appropriate targeted therapies. Tecentriq is also approved in the European Union, United States and more than 90 countries for people with previously treated metastatic non-small cell lung cancer (NSCLC) and for certain types of untreated or previously treated metastatic urothelial carcinoma. About Avastin Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour's ability to grow and spread in the body (metastasise). About the Tecentriq (atezolizumab) and Avastin (bevacizumab) combination There is a strong scientific rationale to support the use of Tecentriq plus Avastin in combination. The Tecentriq and Avastin regimen may enhance the potential of the immune system to combat first-line advanced NSCLC. Avastin, in addition to its established anti-angiogenic effects, may further enhance Tecentriq’s ability to restore anti-cancer immunity, by inhibiting VEGF-related immunosuppression, promoting T-cell tumour infiltration and enabling priming and activation of T-cell responses against tumour antigens. About Roche in cancer immunotherapy For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer. By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients. To learn more about the Roche approach to cancer immunotherapy please follow this link: http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] Socinski M et al. IMpower150: analysis of efficacy in patients (pts) with liver metastases (mets) [ASCO Abstract 9012]. [2] Socinski MA et al. Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC. N Engl J Med 2018;378:2288–2301. [3] Roche. Tecentriq® Summary of Product Characteristics. 2017. [4] GLOBOCAN 2018. Lung cancer: estimated cancer incidence, mortality and prevalence worldwide. World Health Organization. Available from: http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed May 2019. [5] American Cancer Society. What Is Non-Small Cell Lung Cancer? [Internet]: Available from: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html. Accessed May 2019. [6] Riihimäki M et al. Metastatic sites and survival in lung cancer. Lung Cancer 2014;86:78-84. [7] Shiroyama T et al. Clinical characteristics of liver metastasis in nivolumab-treated patients with non-small cell lung cancer. Anticancer Research 2018;38:4723-4729 Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com \- Nicolas Dunant (Head) \- Patrick Barth \- Ulrike Engels-Lange \- Simone Oeschger \- Anja von TreskowAttachment * 190602_MR_ASCO_Lung Cancer_EN

  • Globe Newswire

    Roche and GE Healthcare launch NAVIFY Tumor Board with medical imaging capabilities to enable more personalised treatment decisions in cancer care

    Roche and GE Healthcare launch NAVIFY Tumor Board with medical imaging capabilities to enable more personalised treatment decisions in cancer care * Radiologists can now upload their patient records to the same dashboard as patient files from other disciplines * First collaboration product enables tumour boards to have a more comprehensive view of each patient in one place * Important step in Roche’s personalised healthcare strategy to fit treatments to patients who can benefit most from a specific therapy              Basel, 31 May 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the release of NAVIFY Tumor Board 2.0, the first collaboration product from our partnership with GE Healthcare. Incorporating medical image viewing and storage capabilities with other patient data, the product enables tumour boards - multi-disciplinary teams who determine treatment plans for cancer patients - to have a more comprehensive view of each patient in one place. Bringing together patient medical records from various systems for review by tumour boards can be time-consuming and cumbersome. The integration of GE Healthcare’s medical image viewer into NAVIFY Tumor Board 2.0 enables radiologists to upload their patient records to the same dashboard where patient files from other disciplines in the cancer care team are stored. Having complete patient diagnostic information in one location helps specialists use the limited time they have during tumour boards to review all relevant files quickly and align on the best possible treatment plan for each cancer patient. “This new version of NAVIFY Tumor Board is the first product developed in partnership with GE Healthcare and demonstrates our shared vision of accelerating personalised healthcare,” said Michael Heuer, CEO Roche Diagnostics. “Our mutual focus is on delivering clinical decision support solutions that enable healthcare professionals to make faster, more confident decisions, allowing more personalized treatment based on truly integrated diagnostics.”  “We are delighted to announce the first major milestone of our ongoing collaboration with Roche, as we work together to enable precision healthcare. Workflows around tumour boards can be inefficient, and we hope this single, holistic dashboard - including patient data and images - will enable oncology teams to align more quickly on the most optimal diagnosis and treatment plan for the benefit of each patient,” said Tom McGuinness, President and CEO, GE Healthcare Imaging. The partnership combines Roche expertise in advanced lab testing and the GE Healthcare leadership in medical imaging and monitoring to provide an ecosystem of workflow solutions and apps on an industry-first shared integrated diagnostics platform. The companies are aiming to design products to enable seamless integration and analysis of comprehensive lab and medical imaging data, patient records, medical best practice, real time monitoring and the latest research outcomes. Clinicians will then have confidence that they are making the best possible treatment decision for each patient. The new version of NAVIFY Tumor Board is initially available in the United States and Canada with additional markets to follow in the near future. About the NAVIFY Decision Support portfolio The NAVIFY Decision Support portfolio helps healthcare professionals navigate the increasing complexity of medical and scientific information by transforming large amounts of data into actionable insights -fundamentally changing clinical decision making across the care continuum. NAVIFY Tumor Board, a cloud-based software solution, streamlines and standardizes preparation, facilitation and documentation of treatment decisions by oncology care teams. The NAVIFY portfolio is continuously evolving to include additional solutions that support more personalized, confident treatment decisions for the benefit of each individual patient. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the tenth consecutive year, Roche has been recognised as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com \- Nicolas Dunant (Head) \- Patrick Barth \- Ulrike Engels-Lange \- Simone Oeschger \- Anja von Treskow  Attachment * 190531_ASCO_MR_ Launch of Navify Tumor Board 2.0 _EN

  • GlobeNewswire

    Roche announces FDA approval for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukaemia

    Fixed 12-month treatment with Venclexta plus Gazyva significantly reduced risk of disease progression or death by 67% compared to a current standard-of-care Approval for expanded use of Venclexta offers ...

  • GlobeNewswire

    Roche's personalised medicine entrectinib shrank tumours harbouring NTRK, ROS1 or ALK gene fusions in children and adolescents

    Phase I/II study of entrectinib, an investigational medicine, showed responses in all paediatric tumour types harbouring neurotrophic tyrosine receptor kinase (NTRK), ROS1 or anaplastic lymphoma kinase ...

  • Business Wire

    Genentech’s Personalized Medicine Entrectinib Shrank Tumors Harboring NTRK, ROS1 or ALK Gene Fusions in Children and Adolescents

    – Phase I/II study of entrectinib, an investigational medicine, showed responses in all pediatric tumor types harboring neurotrophic tyrosine receptor kinase , ROS1 or anapla

  • Business Wire

    Genentech Announces FDA Approval for Venclexta Plus Gazyva for People With Previously Untreated Chronic Lymphocytic Leukemia

    OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). “Venclexta plus Gazyva is the only chemotherapy-free option of fixed duration that provides durable responses to help people live longer without progression of their disease, compared to a standard of care,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development.

  • Reuters

    Roche pushes back Spark takeover again as regulatory review drags on

    Swiss drugmaker Roche is pushing back its $4.3 billion (3.3 billion pounds) takeover offer for gene therapy specialist Spark Therapeutics for a third time in recent months, this time until June 14, as a U.S. regulatory review of the deal drags on. Roche and Spark are now due to refile their premerger notification on May 23, "in order to provide the government with additional time," the companies said in a joint statement on Tuesday. Roche has said the Federal Trade Commission (FTC) needed even more time to complete its review.

  • GlobeNewswire

    New Roche test aids clinicians in accelerating tuberculosis diagnosis and treatment by detecting antimicrobial resistance within the world's leading cause of infectious disease deaths

    OTCQX: RHHBY) today announced the CE-IVD launch of the cobas® MTB-RIF/INH test to detect resistance to antibiotics within tuberculosis DNA. This assay is part of the mycobacteria test menu that includes the cobas® MTB and cobas® MAI tests for use on the cobas® 6800/8800 Systems.

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