The FDA granted fast track designation to STRO-002 for treatment of certain women with advanced gynecologic cancer. The designation applies to use of the agent with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who received one to three prior lines of systemic therapy.

Dr. Murat Kalayoglu, CEO at Cartesian Therapeutics, details the cell and gene therapy sector’s advancements in RNA cell therapy and the why behind the company’s decision to build its own wholly-owned GMP manufacturing facility.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for STRO-002. The investigational drug, being developed by Sutro Biopharma, is a folate receptor alpha (FolRα)-targeting antibody-drug conjugate (ADC) for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior lines of systemic therapy. […]