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 (2)	FOLR1 positive	Ovarian Epithelial Tumor	Mirvetuximab soravtansine
FDA (2)	FOLR1 positive	High-Grade Serous Fallopian Tube Cancer	Mirvetuximab soravtansine
FDA (2)	FOLR1 positive	Peritoneal Serous Carcinoma	Mirvetuximab soravtansine

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-03-22	Food and Drug Administration	Indication received traditional approval.