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FDA Approves Mirvetuximab Soravtansine for Patients With FRα-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
On March 22, 2024, the US Food and Drug Administration (FDA) approved mirvetuximab soravtansine for previously treated patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, as detected by an FDA-approved test.
This regulatory decision was based on results from the phase 3, open-label, active-controlled MIRASOL trial.
This trial included 453 patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received up to 3 prior lines of systemic therapy. Patients were randomized on a 1-to-1 basis to receive either 6 mg/kg of intravenous mirvetuximab soravtansine every 3 weeks (adjusted by ideal body weight), or investigator’s choice of chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan) until disease progression or unacceptable toxicity. The major efficacy outcomes included overall survival (OS), investigator-assessed progression-free survival (PFS), and confirmed overall response rate (ORR).
At analysis, median OS was 16.5 months in the mirvetuximab soravtansine arm and 12.7 months in the chemotherapy arm (hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.50 to 0.88; P = .0046). Median PFS was 5.6 months in the mirvetuximab soravtansine arm and 4 months in the chemotherapy arm (HR, 0.65; 95% CI, 0.52 to 0.81; P < .0001). ORR was 42% and 16%, respectively (P < .0001).
The most common adverse reactions (including laboratory abnormalities) occurring in ≥20% of patients included 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.
There is a boxed warning for treatment-related ocular toxicity and includes pneumonitis, peripheral neuropathy, and embryo-fetal toxicity under Warnings and Precautions. The recommended dose of mirvetuximab soravtansine is 6 mg/kg administered intravenously once every 3 weeks in a 21-day cycle, adjusted by ideal body weight until disease progression or unacceptable toxicity.
Source:
FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Published online: March 22, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant-epithelial-ovarian
