Dr. Debu Tripathy breaks down the FDA approval of Enhertu in unresectable or metastatic HR-positive, HER2-low or -ultralow ...

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval from the US Food and Drug Administration (FDA) for an expanded indication of ...

Specifically, Enhertu (trastuzumab deruxtecan) has been cleared to treat HR-positive, HER2-low metastatic breast cancer – an immunohistochemistry (IHC) score of 1+ or 2+ or negative for in situ ...

breast cancer, as determined by an FDA-approved test, that has progressed on 1 or more endocrine therapies in the metastatic setting. Enhertu is a HER2-directed antibody and topoisomerase ...

in the overall trial population of patients with chemotherapy-naive HER2-low or HER2-ultralow metastatic breast cancer. Patients randomly assigned to Enhertu had a median progression-free survival ...

The companies’ sBLA was seeking approval for Enhertu to treat unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer in adult patients who have received at least one ...

The trial showed an ORR of 62.6% for Enhertu compared to 34.4% for chemotherapy in HER2-low and HER2-ultralow metastatic breast cancer. Get real-time earnings alerts before the market moves and ...

1. Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for Enhertu. Roche. News release. January 31 ...

HR+/HER2- breast cancer involves cells that test positive for hormone receptors and negative for HER2 proteins. It's the most ...

The breast cancer market has experienced robust growth, fueled by increased awareness and early detection efforts. Advances in diagnostic and treatme ...

AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...