FDA Accepts ImmunoGen’s BLA of Mirvetuximab Soravtansine for Ovarian Cancer

The FDA has granted a priority review for ImmunoGen’s Biologics License Application (BLA) for its investigational antibody-drug conjugate, mirvetuximab soravtansine, as a monotherapy for patients with previously treated folate receptor alpha-high platinum-resistant ovarian cancer.

The company is also seeking an accelerated approval for the BLA supported by positive data a late-stage trial that demonstrated a response rate of 32.4 percent.

ImmunoGen is conducting an additional study that could potentially allow the accelerated approval to become a full approval. The company expects to release data from this study in early 2023.

The Priority Review designation means the FDA aims to make a decision on the application within six months instead of the standard 10 months. The agency’s Prescription Drug User Fee Act decision date for the BLA is Nov. 28, 2022.