FDA Grants Accelerated Approval to Mirvetuximab Soravtansine for FRα-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

The Food and Drug Administration (FDA) granted accelerated approval to mirvetuximab soravtansine-gynx, a folate receptor alpha directed antibody and microtubule inhibitor conjugate, to treat adult patients with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received 1 to 3 systemic treatment regimens. The FDA also approved the VENTANA FOLR1 RxDx Assay as a companion diagnostic device to select patients for this treatment.

The approval was based on results from the ongoing single-arm, phase 3 Study 0417, which enrolled 106 patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received ≤3 prior lines of systemic therapy, 1 of which had to include bevacizumab. Patients received 6 mg/kg intravenous mirvetuximab soravtansine-gynx every 3 weeks until disease progression or unacceptable toxicity. Tumor response was assessed every 6 weeks for the first 36 weeks. After this period, tumor response was assessed every 12 weeks.

The major efficacy outcome measures were investigator-assessed overall response rate (ORR) and duration of response (DOR). Patients who received at least 1 dose of mirvetuximab soravtansine-gynx (n = 104) experienced a confirmed ORR of 31.7% (95% confidence interval [CI], 22.9 to 41.6) and median DOR of 6.9 months (95% CI, 5.6 to 9.7).

The most common treatment-related adverse events, reported in ≥20% of patients, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.

The prescription also includes a black box warning for ocular toxicity.

Source:

FDA grants accelerated approval to mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer. Press Release. United States Food and Drug Administration. November 14, 2022. Accessed November 15, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant