Blog Coverage AbbVie Received FDA Approval for Treatment for Marginal Zone Lymphoma
Upcoming AWS Coverage on AstraZeneca
LONDON, UK / ACCESSWIRE / January 20, 2017 / Active Wall St. blog coverage looks at the headline from AbbVie Inc. (NYSE: ABBV) as the Company announced on January 19th, 2017, that the US Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL), who require systemic therapy and have received at least one prior anti-CD20-based therapy. Register with us now for your free membership and blog access at:
http://www.activewallst.com/register/
One of AbbVie's competitors within the Drug Manufacturers - Major space, AstraZeneca PLC (NYSE: AZN), is estimated to report earnings on February 02, 2017. AWS will be initiating a research report on AstraZeneca following the release of its next earnings results.
Today, AWS is promoting its blog coverage on ABBV; touching on AZN. Get all of our free blog coverage and more by clicking on the links below:
http://www.activewallst.com/registration-3/?symbol=ABBV
http://www.activewallst.com/registration-3/?symbol=AZN
The Approval Decision
AbbVie stated that the approval in MZL is based on data from the Phase-2, open-label, multi-center, single-arm PCYC-1121 study, which evaluated the safety and efficacy of IMBRUVICA in MZL patients who require systemic therapy and have received at least one prior anti-CD20-based therapy. The efficacy analysis included 63 patients with three sub-types of MZL: mucosa-associated lymphoid tissue, nodal and splenic. The ORR was achieved in nearly 46% of the patients as assessed by an Independent Review Committee (IRC) using criteria adopted from the International Working Group criteria for malignant lymphoma, with efficacy observed across all three MZL sub-types. In the trial, 3.2% of patients had a complete response (CR) and 42.9% of patients had a partial response (PR).
AbbVie stated that this indication is approved under accelerated approval based on overall response rate (ORR), and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
What is Marginal Zone Lymphoma?
Marginal zone lymphoma (MZL) is a slow-growing B-cell lymphoma arising from white blood cells (lymphocytes) at the edges of lymphoid tissue.3 MZL accounts for approximately 8% of all cases of non-Hodgkin's lymphoma in adults, and the median age of diagnosis is 65 years old.3,4 There are three sub-types of MZL: mucosa-associated lymphoid tissue, nodal and splenic.3.
About IMBRUVICA
IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells. IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.
The FDA approval marks the fifth patient population CLL, SLL, WM, along with previously-treated MCL and MZL for whom IMBRUVICA is now approved and broadens the number of patients who may be treated with the medication.
IMBRUVICA was first approved for patients with MCL who have received at least one prior therapy in November 2013. In February 2014, IMBRUVICA was initially approved in CLL patients who have received at least one prior therapy. In July 2014, the therapy received approval for CLL patients with 17p deletion, and by March 2016, the therapy was approved as a frontline CLL treatment. IMBRUVICA was approved for patients with WM in January 2015. In May 2016, IMBRUVICA was approved in combination with bendamustine and rituximab (BR) for patients with previously treated CLL/SLL.
IMBRUVICA was one of the first medicines to receive US FDA approval via the new Breakthrough Therapy Designation pathway.
Stock Performance
At the closing bell, on Thursday, January 19, 2017, AbbVie's stock was marginally down 0.45%, ending the trading session at $61.38. A total volume of 5.38 million shares were traded at the end of the day. In the last three months and previous twelve months, shares of the Company have advanced 0.73% and 11.51%, respectively. The stock is trading at a PE ratio of 16.51 and has a dividend yield of 4.17%.
Active Wall Street:
Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.
AWS has not been compensated; directly or indirectly; for producing or publishing this document.
PRESS RELEASE PROCEDURES:
The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, for further information on analyst credentials, please email info@activewallst.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by AWS. AWS is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.
NO WARRANTY
AWS, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. AWS, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, AWS, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.
NOT AN OFFERING
This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither AWS nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.activewallst.com/disclaimer/.
CONTACT
For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:
Email: info@activewallst.com
Phone number: 1-858-257-3144
Office Address: 3rd floor, 207 Regent Street, London, W1B 3HH, United Kingdom
CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.
SOURCE: Active Wall Street
