that has progressed on 1 or more endocrine therapies in the metastatic setting. Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on ...

Under the new indication, eligible patients can receive Enhertu after endocrine therapy, without first undergoing chemotherapy. The decision was supported by data from the Phase ... to 8.1 months ...

Dr. Debu Tripathy discusses the FDA approval of Enhertu in unresectable or metastatic hormone receptor HR+, HER2-low or -ultralow breast cancer.

The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...

Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus investigator’s choice of chemotherapy (capecitabine, paclitaxel or nab-paclitaxel) in patients with HR-positive, ...

ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC ...

The FDA approval of AstraZeneca’s sBLA was based on positive data from the phase III DESTINY-Breast06 study, which compared Enhertu to chemotherapy ... as compared to 8.1 months for chemotherapy.

Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY ... in Solid Tumors v1.1 In the HER2-low ...

The FDA approval of AstraZeneca’s sBLA was based on positive data from the phase ... from Enhertu sales under Alliance revenues. In the first nine months of 2024, Enhertu generated $1.05 billion ...