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Immunogen Files FDA Application for Full Elahere Ovarian Cancer Approval

NEW YORK – Immunogen said on Tuesday that it has filed a supplementary biologics application with the US Food and Drug Administration to convert the accelerated approval for Elahere (mirvetuximab soravtansine) in folate receptor alpha (FRα)-positive advanced ovarian cancer into a full approval.

The FDA granted priority review to the application, which would make the antibody-drug conjugate — which has been available under accelerated approval since November 2022 — fully available for FRα-positive ovarian, fallopian tube, or primary peritoneal cancer patients who are platinum-resistant and who have previously received between one and three lines of treatment.

Immunogen's application includes data from the confirmatory Phase III MIRASOL trial, presented in June, in which Elahere improved patients' progression-free survival, objective response rate, and overall survival versus chemotherapy. 

Elahere involves a FRα-binding antibody linked to a cytotoxic payload. Immunogen has also filed for the drug's approval in Europe and in China.

The FDA is expected to make its decision on whether to grant Elahere full approval on April 5, 2024.