Enhertu FDA Approval History
FDA Approved: Yes (First approved December 20, 2019)
Brand name: Enhertu
Generic name: fam-trastuzumab deruxtecan-nxki
Dosage form: Injection
Company: AstraZeneca and Daiichi Sankyo Company, Limited
Treatment for: Breast Cancer, Gastric Cancer
Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting; and adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
Development Timeline for Enhertu
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