Tag Archives: metastatic breast cancer

Novartis Presents ASCO Data Showing Kisqali’s Efficacy and Tolerability in High-Risk Early Breast Cancer Patients

(IN BRIEF) Novartis has presented new data from the Phase III NATALEE trial at ASCO 2025, showcasing Kisqali’s ability to reduce the risk of recurrence in pre-menopausal patients with high-risk early breast cancer. The data reveals a 33% reduction in … Read the full press release

Roche Expands FDA Approval of PATHWAY® HER2 Test for HER2-Ultralow Breast Cancer Status

(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

BioNTech and DualityBio Initiate Phase 3 Trial for HER2-Targeting ADC in Metastatic Breast Cancer

(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

FDA Accepts AstraZeneca’s NDA for Capivasertib Combination Therapy in Advanced Breast Cancer

(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