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


Plus: Approvals in earlier cancer lines for Rybrevant and Opdivo, and new indications for four more products

By Gunjan Ohri, Data Content Analyst 

April 27, 2024 12:10 AM UTC

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). …