ImmunoGen Receives FDA's Priority Review For ELAHERE In Platinum-Resistant Ovarian Cancer

(RTTNews) - ImmunoGen, Inc. (IMGN) Tuesday announced that the FDA has filed the supplemental Biologics License Application for the accelerated approval of ELAHERE for the treatment of patients with folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received prior treatments.

Further, the company noted that the application has been granted Priority Review designation with a Prescription Drug User Fee Act action date of April 5, 2024.

ImmunoGen said now it is one step closer to securing full approval of ELAHERE in the US and establishing this novel ADC as the standard of care in FRa-positive platinum-resistant ovarian cancer.

The confirmatory Phase 3 MIRASOL trial of ELAHERE in platinum-resistant ovarian cancer forms the basis of the sBLA.

According to the company, ELAHERE has 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. Further, a marketing authorization application for ELAHERE in Europe and a new drug application in China have been accepted.