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Enhertu FDA Approval History

Last updated by Judith Stewart, BPharm on April 9, 2024.

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, Non-Small Cell Lung Cancer, Solid Tumors

Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate used for the treatment of HER2-positive breast cancer, HER2-low breast cancer, HER2-mutant non-small cell lung cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and HER2-positive solid tumors.

Development timeline for Enhertu

Apr  6, 2024Approval Enhertu Approved in the US as First Tumor-Agnostic HER2-Directed Therapy for Previously Treated Patients with Metastatic HER2-Positive Solid Tumors
Aug 12, 2022Approval Enhertu Approved in the US as the First HER2-Directed Therapy for Patients with Previously Treated HER2-Mutant Metastatic Non-Small Cell Lung Cancer
Aug  6, 2022Approval Enhertu Approved in the US as the First HER2-Directed Therapy for Patients with HER2-Low Metastatic Breast Cancer
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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