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# ImmunoGen’s Elahere OK’d for Several Cancers
- URL: https://www.fdaweb.com/immunogens-elahere-okd-for-several-cancers/
- Published: 2022-11-14T12:00:00.000Z
- Updated: 2026-09-14T18:06:15.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153195

FDA has granted ImmunoGen an accelerated approval for Elahere (mirvetuximab soravtansine-gynx) for treating adult patients with folate receptor alpha (FRa)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Approval was based on objective response rate (ORR) and duration of response (DOR) data from the pivotal SORAYA trial, the company says, describing the therapy as a first-in-class antibody-drug conjugate directed against FRa, a cell-surface protein highly expressed in ovarian cancer. “With an indication for use regardless of prior treatment with Avastin, we believe Elahere is positioned to become the new standard of care for patients with FRa-positive platinum-resistant ovarian cancer,” it adds.

ImmunoGen says the therapy was approved with a boxed warning for ocular toxicity, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. The most common adverse reactions (observed in 20% or more patients) were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.