Enhertu (fam-trastuzumab deruxtecan-nxki) has received FDA approval for HR-positive, HER2-low, HER2-ultralow metastatic breast cancer.

Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...

FDA approves Enhertu for metastatic breast cancer with HER2-low or HER2-ultralow expression after showing significant ...

AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application ...

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

Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners' Datroway for a related type of breast ...

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 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 expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...

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 ...

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.

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 ...