Tag Archives: HER2-Low

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

AstraZeneca and Daiichi Sankyo’s Enhertu Receives Priority Review for HER2-Low and Ultralow Breast Cancer Patients Pre-Chemotherapy

(IN BRIEF) AstraZeneca and Daiichi Sankyo announced that their drug Enhertu (trastuzumab deruxtecan) has been granted Priority Review by the US FDA for treating patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer who have previously undergone endocrine therapy. … Read the full press release

Positive Results from DESTINY-Breast06 Trial: Enhertu Shows Promise in HER2-Low and HER2-Ultralow Breast Cancer Patients

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Enhertu, a HER2-directed antibody drug conjugate (ADC), has demonstrated significant progress in treating HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy. The high-level results from the DESTINY-Breast06 Phase … Read the full press release