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

Get Instant Summarized Text (Gist) The FDA has approved Enhertu for treating adults with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow breast cancer. This approval follows the ...

Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier: ...

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 ...

MONDAY, Feb. 3, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic ...

Enhertu received an FDA nod in HER2-ultralow breast cancer in late January, its seventh agency approval, for treatment following the disease’s progression after endocrine therapy. Roche’s ...

Roche has received FDA approval for a label expansion of its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which identifies patients with HR–positive, HER2-ultralow metastatic ...

The FDA has approved Swiss pharmaceutical company Roche’s first companion diagnostic for identifying those patients with HER2 low-metastatic breast cancer who are eligible for ENHERTU. The ...

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