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# ImmunoGen sBLA for Elahere Seeks Full Approval
- URL: https://www.fdaweb.com/immunogen-sbla-for-elahere-seeks-full-approval/
- Published: 2023-12-05T12:00:00.000Z
- Updated: 2026-09-14T14:17:46.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155920

FDA has accepted for priority review an ImmunoGen supplemental BLA to convert the accelerated approval of Elahere (mirvetuximab soravtansine-gynx) to full approval for treating patients with folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been given one to three prior systemic treatment regimens. The agency has set a review action target date of 4/5/2024.

The submission is based on data from the confirmatory Phase 3 MIRASOL trial that showed Elahere demonstrated “statistically significant and clinically meaningful improvements in progression-free survival, objective response rate, and overall survival compared to investigator's choice (IC) of single-agent chemotherapy,” the company says. “Elahere demonstrated a tolerable safety profile compared to IC chemotherapy, consisting predominantly of low-grade ocular and gastrointestinal events.”

Elahere was originally granted accelerated approval 11/2022 based on data from the pivotal SORAYA trial. It is described by ImmunoGen as a first-in-class antibody-drug conjugate “comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.”