(IN BRIEF) Roche has announced that the FDA has expanded the approval of its PATHWAY® HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to identify HER2-ultralow status in HR-positive, HER2-negative metastatic breast cancer patients. This new approval offers a potential treatment … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged breast cancer, DESTINY-Breast06 trial, diagnostic solutions, Enhertu, FDA, FDA approval, HER2-Low, HER2-targeted therapy, HER2-Ultralow, HR-positive, metastatic breast cancer, PATHWAY HER2, Personalized Treatment, Roche, treatment options
(IN BRIEF) BioNTech and Duality Biologics have announced the commencement of a pivotal Phase 3 trial for BNT323/DB-1303, a next-generation antibody-drug conjugate (ADC) targeting the Human Epidermal Growth Factor Receptor 2 (HER2) in metastatic breast cancer. The trial will enroll … Read the full press release
(IN BRIEF) AstraZeneca’s new drug application (NDA) for capivasertib, in combination with Faslodex, has been accepted and granted Priority Review by the US FDA for the treatment of advanced breast cancer. The NDA is being reviewed under Project Orbis, which … Read the full press release
Posted in Healthcare, Pharma & Biotech, United Kingdom
Tagged 2022 San Antonio Breast Cancer Symposium, AstraZeneca, breast cancer, CAPItello-291 Phase III, capivasertib, CDK4/6 inhibitors, endocrine therapies, Faslodex, FDA, Food and Drug Administration, fulvestran, hormone receptor, metastatic breast cancer, NDA, New Drug Application, Priority Review, Susan Galbraith, The New England Journal of Medicine
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