DAIICHI SANKYO — Enhertu FDA Review (NDA/BLA 761139, 2025)

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The FDA approved Daiichi Sankyo's Enhertu (fam-trastuzumab deruxtecan-nxki) on April 5, 2024, for various HER2-positive/low metastatic cancers and solid tumors, including accelerated approvals. This oncology drug's indications, dosage, and administration guidelines are detailed, alongside potential adverse reactions like interstitial lung disease, neutropenia, and left ventricular dysfunction, with management strategies. Extensive clinical trials (e.g., DESTINY-Breast02, DESTINY-PanTumor02) support Enhertu's safety and efficacy, providing data on adverse event frequency, severity, and impact on treatment. Efficacy results, including objective response rates, duration of response, overall survival, and progression-free survival, are presented for various cancer types. The FDA's multidisciplinary review, including pharmacokinetic/pharmacodynamic analyses and clinical inspection findings, led to accelerated approval for unresectable or metastatic HER2-positive (IHC 3+) solid tumors, contingent on confirmatory trials. Post-marketing requirements include completing ongoing trials and conducting pediatric studies. The benefit-risk ratio was deemed positive, with labeling and packaging reviewed for acceptability.

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