FierceBiotech6d
Roche's Enhertu companion diagnostic secures new FDA approval in HER2-ultralow breast cancer
The company’s PATHWAY HER2 antibody test—used to help screen patients for treatment with Enhertu (trastuzumab deruxtecan-nxki), the antibody-drug conjugate jointly developed by Daiichi Sankyo ...
pharmaphorum1d
Boost to Enhertu's prospects as FDA clears Roche diagnostic
Just days after the FDA approved AstraZeneca and Daiichi Sankyo's Enhertu for a potentially lucrative new use, the regulatory has now cleared a diagnostic test that could help unlock the drug's ...
Pharm Exec6d
FDA Approves Expanded Label for Roche's Companion Diagnostic to Identify HER2-Ultralow Breast Cancer Patients Eligible for Enhertu
2. Enhertu approved in the US as first HER2-directed therapy for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more endocrine therapies.
pharmaphorum1d
EU clears Enhertu for HER2-low breast cancer
In the 557-patient study, Enhertu reduced the risk of disease progression or death by 50%, whilst improving overall survival by 36% compared to chemotherapy – translating to an extra half year ...
Too Old to Operate6d
FDA Approval Expands Earlier Use of Enhertu for Metastatic Breast Cancer
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 hormone ...