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Enhertu FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 25, 2021.

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

May  6, 2022Approval  Enhertu Approved in the US for Patients with HER2-Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen
Apr 27, 2022Enhertu Granted Breakthrough Therapy Designation in U.S. for Patients with HER2 Low Metastatic Breast Cancer
Jan 15, 2021Approval  Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer
Dec 20, 2019Approval  FDA Approves Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens
Oct 17, 2019[Fam-] Trastuzumab Deruxtecan Granted FDA Priority Review for Treatment of Patients with HER2-positive Metastatic Breast Cancer

Further information

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