Regulatory approval

Published by the Food and Drug Administration. Approved

ELAHERE is a folate receptor alpha (FRalpha)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FR-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.

This is written in the approval document.

Citation

ImmunoGen, Inc. Elahere (mirvetuximab soravtansine-gynx) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761310Origs005lbl.pdf. Revised March 2024. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) FOLR1 positive Ovarian Epithelial Tumor Mirvetuximab soravtansine
FDA (1) FOLR1 positive High-Grade Serous Fallopian Tube Cancer Mirvetuximab soravtansine
FDA (1) FOLR1 positive Peritoneal Serous Carcinoma Mirvetuximab soravtansine