The U.S. Food and Drug Administration (FDA) announced the approval of a supplemental application for Enhertu (fam-trastuzumab deruxtecan-nxki) on April 27, 2026. This regulatory action specifically addresses an update to the drug's efficacy profile, as detailed in the supplemental Biologics License Application (BLA) 761139 S-39.
Background
Enhertu is a drug developed by Daiichi Sankyo. This supplemental approval pertains to an update regarding the drug's efficacy, as classified by the FDA.
What this means
The FDA's approval of this supplemental application for Enhertu's efficacy signifies that new data supports an expanded or refined therapeutic benefit. This could involve a new indication, a different patient population, or an improved efficacy profile within an existing indication. Healthcare professionals should refer to the full prescribing information and updated drug label for comprehensive details on the specific changes and implications for patient care.
Source
The information regarding this supplemental approval was sourced from the U.S. Food and Drug Administration (FDA) website. The approval for Biologics License Application (BLA) 761139 S-39 for Enhertu was posted on April 27, 2026, on accessdata.fda.gov.