On August 5, 2022, the FDA approved a supplemental application for Enhertu (fam-trastuzumab deruxtecan-nxki). This approval, granted to sponsor Daiichi Sankyo, specifically relates to the drug's efficacy profile.
Background
The drug involved in this action is Enhertu (fam-trastuzumab deruxtecan-nxki). This supplemental approval addresses aspects of the drug's efficacy, as indicated by the FDA's classification of the application.
What this means
A supplemental FDA approval for efficacy typically signifies an update to the drug's prescribing information based on new clinical data. This could involve an expanded indication, a new patient population for whom the drug has demonstrated efficacy, or updated efficacy data for an already approved use. Clinicians should consult the official prescribing information for Enhertu to understand the specific changes and their implications for patient care following this efficacy-related approval.
Source
The information regarding this supplemental approval was obtained from the FDA's official database. The approval for BLA 761139 S-22 was documented on August 5, 2022, and is accessible via accessdata.fda.gov.