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FDA Grants Mirvetuximab Full Approval for Ovarian Cancer
The US Food and Drug Administration granted full approval to mirvetuximab soravtansine-gynx (Elahere) for adults with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
AbbVie noted in a press release that its antibody-drug conjugate is the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer. It could become a "new standard of care for folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer (PROC)," the company said.
Mirvetuximab soravtansine was previously granted accelerated approval for the indication in November 2022.
The decision to grant full approval was made after reviewing the results of the MIRASOL study, which included 453 patients who had received up to three lines of previous systemic therapy. The patients were randomly assigned to receive either mirvetuximab soravtansine at a dose of 6 mg/kg every 3 weeks or the investigator's choice of chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan) until disease progression or unacceptable toxicity.
Median overall survival was 16.5 months in the mirvetuximab soravtansine arm vs 12.7 months with chemotherapy. Median progression-free survival (PFS) was 5.6 months and overall response rate was 42% with the antibody-drug conjugate vs a PFS of 4 months and a response rate of 16% in the chemotherapy group.
Mirvetuximab soravtansine carries a boxed warning of ocular toxicity, as well as warnings and precautions about pneumonitis, peripheral neuropathy, and embryo-fetal toxicity.
Twenty percent or more of the patients in MIRASOL experienced increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils.
The recommended dose is 6 mg/kg, adjusted for ideal body weight, administered once every 3 weeks until disease progression or unacceptable toxicity.
According to drugs.com, 100 mg/29 mL of mirvetuximab soravtansine-gynx costs $6690.15.
M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com
