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Roche Holding AG (RHO.HA)
- GlobeNewswire
Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk
Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial infarction and stroke.1The Roche Diagnostics Tina-quant® Lp(a) assay measures lipoprotein (a) in a person’s bloodstream, and will be made available on Roche’s installed base of over 90,000 serum work area (SWA) systems worldwide. The test has been developed in collaboration with Amgen. Basel, 22 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announc
- Business Wire
FDA Grants Breakthrough Therapy Designation to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation
SOUTH SAN FRANCISCO, Calif., May 21, 2024--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic bre
- Globe Newswire
FDA grants Breakthrough Therapy Designation to Roche’s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation
The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting1Approximately 40% of people with HR-positive breast cancer have a PIK3CA mutation and often face poorer prognosis and resistance to endocrine treatment2,3 This is the 29th Breakthrough Therapy Designation for Roche’s oncology portfolio, a testament to our enduring ambition to deliver tran
