champpixs
The U.S. Food and Drug Administration has granted ImmunoGen (NASDAQ:IMGN) a priority review for its supplemental biologics license application of ovarian cancer drug Elahere (mirvetuximab soravtansine-gynx).
The priority review for full approval has a Prescription Drug User Fee Act action date of April 5, 2024. Elahere aims to treat patients with folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Michael Vasconcelles, ImmunoGen’s executive vice president, said: “This regulatory milestone, achieved just over one year after Elahere’s accelerated approval, underscores the significance of the [confirmatory Phase 3 MIRASOL trial] data and the broader data set seen to date with Elahere.”
Elahere received accelerated approval by the FDA in November 2022. The drug is also being reveiwed by the European Medicines Agency and the National Medical Products Administration of China.