FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

Regulatory approval: On March 22, 2024, the FDA granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere) for adults with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1–3 prior systemic regimens, with selection by an FDA-approved test. Efficacy supporting the post-marketing requirement came from the randomized MIRASOL (Study 0416) trial, showing improved OS, PFS, and ORR versus investigator’s choice chemotherapy.

FDA regulatory news (accelerated approval)

On March 22, 2024, the FDA approved mirvetuximab soravtansine-gynx (Elahere; ImmunoGen, now part of AbbVie) for adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1–3 prior systemic treatment regimens. Patients are selected using an FDA-approved test. The product previously received accelerated approval for this indication; FDA noted that MIRASOL results satisfy the prior post-marketing requirement.

Key efficacy evidence (MIRASOL; Study 0416; NCT04209855)

Multicenter, open-label, active-controlled, randomized trial (n=453) in FRα-positive disease by VENTANA FOLR1 (FOLR1-2.1) RxDx. Randomization 1:1 to:

  • Mirvetuximab soravtansine-gynx 6 mg/kg (adjusted ideal body weight) IV q3w, or
  • Investigator’s choice chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan)

Outcomes (mirvetuximab vs chemotherapy):

  • OS: 16.5 vs 12.7 months (HR 0.67, 95% CI 0.50–0.88; p=0.0046)
  • PFS: 5.6 vs 4.0 months (HR 0.65, 95% CI 0.52–0.81; p<0.0001)
  • ORR: 42% vs 16% (p<0.0001)

Safety and dosing highlights from labeling

Label includes a Boxed Warning for ocular toxicity; Warnings/Precautions include pneumonitis, peripheral neuropathy, and embryo-fetal toxicity. Recommended dose: 6 mg/kg (adjusted ideal body weight) IV every 3 weeks until progression or unacceptable toxicity. The application received priority review.

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