Posted by Michael Wonder on 18 Jun 2018
ImmunoGen announces FDA fast track designation for mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer
18 June 2018 - ImmunoGen today announced that the U.S. FDA has granted fast track designation for its lead program, mirvetuximab soravtansine.
The designation is for the treatment of patients with medium to high folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer who received at least one, but no more than three prior systemic treatment regimens, and for whom single-agent chemotherapy is appropriate as the next line of therapy.
Mirvetuximab soravtansine is being evaluated in the FORWARD I Phase 3 trial. The trial is designed to randomize 333 patients 2:1 to receive either mirvetuximab soravtansine or the physician's choice of single-agent chemotherapy.
