On November 4, 2022, the FDA approved a supplemental application for Enhertu (fam-trastuzumab deruxtecan-nxki), indicating an expansion of its approved uses based on new efficacy data. This approval was granted to sponsor DAIICHI SANKYO.
Background
Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate. The FDA granted this supplemental approval for efficacy, building upon its existing approvals for various indications. This type of approval signifies that new clinical evidence supports the drug's effectiveness for an additional use.
What this means
A supplemental efficacy approval from the FDA signifies that Enhertu has demonstrated effectiveness for an additional indication or patient population not covered by its previous approvals. While the specific details of this new indication are not provided in the source data, such approvals allow healthcare providers to prescribe the drug for a broader range of patients or conditions, based on new clinical evidence. This expands the potential therapeutic utility of Enhertu in clinical practice, offering more treatment options to patients who may benefit from its mechanism of action.
Source
The information regarding this supplemental approval was sourced from the FDA's official database. The approval for BLA 761139 S-24, concerning Enhertu (fam-trastuzumab deruxtecan-nxki), was recorded on November 4, 2022, and is accessible on accessdata.fda.gov.