manilatimes1h
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, ...
Monthly Prescribing Reference2d
Enhertu Approved for HR+, HER2-Low/Ultralow Metastatic Breast Cancer
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: ...
Yahoo Finance3d
FDA Expands Label of AZN's Enhertu for New Breast Cancer Indication
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 ...
FiercePharma3d
AZ, Daiichi's Enhertu nabs 7th FDA nod, including in 'HER2-ultralow' use, in breast cancer first
The U.S. regulator has cleared Enhertu as the first HER2-directed treatment for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more ...
Healio3d
FDA expands Enhertu approval for breast cancer
Trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) is a HER2-directed antibody-drug conjugate. The agent is approved in the United States for several indications, including treatment of ...
Benzinga.com3d
FDA Approves AstraZeneca, Daiichi Sankyo's Enhertu For Certain Type Of Breast Cancer Patients
Enhertu reduced the risk of disease progression or death by 36%, with a median PFS of 13.2 months versus 8.1 months for chemotherapy. The trial showed an ORR of 62.6% for Enhertu compared to 34.4% ...