FDA D.I.S.C.O. Burst Edition: FDA approval of Elahere (mirvetuximab soravtansine-gynx) for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer
Regulatory approval: On Nov 14, 2022, the FDA granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere) for adults with folate receptor alpha (FRα)–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1–3 prior systemic regimens. Approval was supported by the single-arm Study 0417 (n=106), with confirmed ORR 31.7% and median DOR 6.9 months in the efficacy-evaluable population. The FDA also approved the VENTANA FOLR1 RxDx Assay as a companion diagnostic.
FDA accelerated approval (regulatory news)
Date: 2022-11-14
Agency: FDA
Action: Accelerated approval
The FDA granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere) for adult patients with folate receptor alpha (FRα)–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic treatment regimens. Patients are selected using an FDA-approved test.
The FDA also approved the VENTANA FOLR1 RxDx Assay as a companion diagnostic for patient selection.
Supporting evidence
Efficacy was evaluated in Study 0417, a single-arm trial enrolling 106 patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients could have up to three prior systemic therapy lines, and all patients were required to have received bevacizumab. Key exclusions included corneal disorders/ocular conditions requiring ongoing treatment, >Grade 1 peripheral neuropathy, and noninfectious interstitial lung disease.
Treatment was mirvetuximab soravtansine-gynx 6 mg/kg (adjusted ideal body weight) IV every 3 weeks until progression or unacceptable toxicity. Primary efficacy outcomes were investigator-assessed ORR and DOR per RECIST v1.1. In the efficacy-evaluable population, confirmed ORR was 31.7% and median DOR was 6.9 months.
Safety
Common adverse reactions (>20%) included vision impairment, fatigue, AST/ALT increases, nausea, keratopathy, abdominal pain, lymphocyte decrease, peripheral neuropathy, and diarrhea. Labeling includes a boxed warning for ocular toxicity.