On August 11, 2022, the FDA approved a supplemental application for Enhertu (fam-trastuzumab deruxtecan-nxki). This approval, classified for efficacy, was submitted by sponsor Daiichi Sankyo.
What this means
This supplemental approval indicates that Enhertu has demonstrated additional efficacy for an expanded use or patient population. While the specific new indication is not detailed in this announcement, such approvals typically broaden the therapeutic scope of the drug, allowing it to benefit a wider range of patients who could not previously be treated with it, or offering a new treatment option for an existing patient population. Clinicians should consult the updated label for full details on the expanded use.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA). The approval for BLA 761139 S-21 was posted on August 11, 2022, on accessdata.fda.gov.