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The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Nov. 28, 2022.
The FDA has accepted the biologics license application (BLA) for ImmunoGen’s mirvetuximab soravtansine as a monotherapy for patients with ovarian cancer. The application has been granted priority review designation and FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 28, 2022.
Mirvetuximab soravtansine (IMGN853) is a first-in-class antibody-drug conjugate
comprising a folate receptor alpha-binding antibody, cleavable linker, and a potent tubulin-targeting agent, to kill the targeted cancer cells. It is intended for patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with one to three prior systemic treatments.
The application is based on data from the pivotal phase 3 SORAYA trial. Top-line data were announced in November 2021 and full data from the study were presented at the Society of Gynecologic Oncology annual meeting in March 2022. This trial enrolled 106 patients with a median of three prior lines of therapy. The objective response rate was 32.4%, and the median progression-free survival was 4.3 months.
Treatment-related adverse events led to dose reductions in 19% of patients, dose delays in 32% of patients, and discontinuations in 7% of patients. The most common treatment-related adverse events were low-grade and generally reversible, including blurred vision, keratopathy, and nausea.
“Patients with platinum-resistant ovarian cancer have limited treatment options, and these are associated with low response rates and significant toxicity,” Ursula Matulonis, M.D., chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, professor of medicine at the Harvard Medical School, and SORAYA Co-Principal Investigator, said in a press release.
ImmunoGen continues to enroll patients in the confirmatory MIRASOL trial. The company expects to announce top-line data from this study in early 2023.