The FDA approved a supplemental application for Enhertu (trastuzumab deruxtecan) for efficacy on May 15, 2026. This approval was for a supplemental Biologics License Application (BLA 761139 S-41) submitted by sponsor DAIICHI SANKYO, indicating an expansion or update related to the drug's effectiveness.
Background
Enhertu (trastuzumab deruxtecan) is a drug developed by DAIICHI SANKYO. The FDA's action on this supplemental application pertains to the drug's efficacy profile, as indicated by the classification 'Efficacy' for BLA 761139 S-41.
What this means
The FDA's approval of a supplemental application for Enhertu (trastuzumab deruxtecan) specifically for efficacy suggests an update or expansion of its approved uses or patient population based on new data. Supplemental applications are typically submitted to add new indications, update dosing information, or modify the patient population for an already approved drug. This particular approval, classified as an 'Efficacy' supplement, confirms that new data supported a change related to the drug's effectiveness, potentially broadening its clinical utility for healthcare providers and patients.
Source
This information was sourced from the FDA's official database. The supplemental approval for Enhertu (fam-trastuzumab deruxtecan-nxki) for efficacy (BLA 761139 S-41) was recorded on May 15, 2026, and is accessible via accessdata.fda.gov.