ImmunoGen’s sBLA for Elahere in ovarian cancer granted priority review by FDA

ImmunoGen announced that the FDA has filed the supplemental Biologics License Application – sBLA – supporting the conversion of the accelerated approval of Elahere – mirvetuximab soravtansine-gynx – for the treatment of patients 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 to full approval. The application has been granted Priority Review designation with a Prescription Drug User Fee Act action date of April 5, 2024. The confirmatory Phase 3 MIRASOL trial of ELAHERE in platinum-resistant ovarian cancer forms the basis of the sBLA. In the MIRASOL trial, Elahere demonstrated statistically significant and clinically meaningful improvements in progression-free survival, objective response rate, and overall survival compared to investigator’s choice of single-agent chemotherapy. Elahere demonstrated a tolerable safety profile compared to IC chemotherapy, consisting predominantly of low-grade ocular and gastrointestinal events. Elahere was granted accelerated approval by the FDA in November 2022 based on data from the pivotal SORAYA trial. A Marketing Authorization Application for Elahere in Europe has been accepted by the European Medicines Agency and a New Drug Application in China has been accepted by the National Medical Products Administration of China.