Sutro Biopharma Gains Fast Track Status for Ovarian Cancer Drug
Sutro Biopharma has won FDA Fast Track designation for STRO-002, its experimental ovarian cancer antibody-drug conjugate.
The agency granted the designation for treatment of women with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have undergone at least one previous line of therapy.
The drug has shown “encouraging” preliminary activity and tolerability in a phase 1 study, said Sutro’s Chief Medical Officer, Arturo Molina.
The Fast Track designation is reserved for investigational therapies for serious or life-threatening conditions that could address unmet medical needs. Sponsors who receive the designation interact more frequently with the FDA to discuss their drug development plan and are eligible to receive a Priority Review and accelerated approval.