Oncology News Central (ONC)FDA Approves Mirvetuximab Soravtansine for FRα-positive, Platinum-Resistant Ovarian Cancer

Advancements in Targeted Therapy: Mirvetuximab Soravtansine Offers New Hope for Platinum-Resistant Ovarian Cancer Patients

The US Food and Drug Administration (FDA) has granted full approval to mirvetuximab soravtansine-gynx (Elahere) for the treatment of adults with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, marking a significant advancement in the therapeutic landscape for these patients. This approval, transitioning from accelerated to full status, is anchored on the compelling results of the MIRASOL clinical trial, showcasing notable improvements in survival rates and response to treatment compared to conventional chemotherapy.

Key Points:

• The FDA’s full approval of mirvetuximab soravtansine is for adults with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have undergone 1-3 prior systemic therapies.
• Approval follows the MIRASOL phase 3 trial, demonstrating significant improvements in overall survival, progression-free survival, and overall response rate for patients treated with mirvetuximab soravtansine compared to chemotherapy.
• The study included 453 patients, randomizing them to receive either the antibody-drug conjugate or an investigator’s choice of chemotherapy, highlighting a personalized approach to treatment.
• Mirvetuximab soravtansine showed a median overall survival of 16.5 months versus 12.7 months for chemotherapy, indicating a clear survival advantage.
• Progression-free survival was also better in the mirvetuximab soravtansine group, with a median of 5.6 months compared to 4.0 months in the chemotherapy group.
• The treatment demonstrated a 42% overall response rate, significantly higher than the 16% observed with chemotherapy.
• Ocular toxicity, pneumonitis, peripheral neuropathy, and embryo-fetal toxicity were noted as potential side effects, with a specific Boxed Warning for ocular toxicity.
• Common adverse reactions include changes in liver enzymes, fatigue, blurred vision, and gastrointestinal symptoms, among others.
• The recommended dosing regimen for mirvetuximab soravtansine is 6 mg/kg of adjusted ideal body weight, administered intravenously every three weeks.

“Mirvetuximab soravtansine has fewer serious side effects, especially those that can lead to stopping treatment, compared to standard chemotherapies for patients with platinum-resistant ovarian cancer. This, coupled with the overall survival advantage, demonstrates progress and offers hope for these patients.”
– Merry J. Markham, MD

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