FDA label expansions: March brought full approvals of Elahere, Rybrevant

Highlights among FDA’s supplemental approvals in March include conversions of accelerated approvals for two drugs, and label expansions to earlier treatment lines or new indications for half a dozen products.

After receiving accelerated approval in November 2022, FDA granted Elahere mirvetuximab soravtansine, an FOLR1 antibody-drug conjugate from  AbbVie Inc. (NYSE:ABBV), full approval based on the results of the confirmatory Phase III MIRASOL trial. In the study, which compared Elahere with chemotherapy in platinum-resistant ovarian cancer patients who had received three prior therapies, Elahere led to a median overall survival of 16.46 months vs. 12.75 months (HR=0.67; p=0.0046). ...