Sutro Biopharma, Inc. announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for STRO-002, 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.
"We are pleased with the FDA's decision to grant Fast Track designation for STRO-002 and welcome the opportunity to have more frequent interactions with the agency," said Dr. Arturo Molina, Chief Medical Officer of Sutro Biopharma. "We continue to be enthused by the potential of the STRO-002 program, which has shown encouraging preliminary activity and tolerability in our Phase 1 dose-escalation study in ovarian cancer, and plan to continue to work with the FDA to potentially accelerate our clinical and regulatory efforts."
STRO-001-GM1 is a Phase 1 trial for STRO-002 for patients with advanced ovarian cancer that have progressed or relapsed after standard of care treatments, to assess efficacy, safety, and tolerability. The dose-escalation cohort has been completed and the dose-expansion cohort has enrolled patients from sites in the U.S. and in Spain, with enrollment ongoing. Patients are not pre-selected for FolRα expression but are required to provide a tissue sample for FolRα analysis prior to study treatment. Patients are randomized 1:1 and treated with STRO-002 at either 4.3 or 5.2 mg/kg every three weeks.
Bill Newell, Chief Executive Officer of Sutro Biopharma added, "Receiving Fast Track designation is an important recognition for STRO-002 as a potentially best-in-class FolRα ADC for women with ovarian cancer. We look forward to further collaboration with the FDA to bring this potentially important therapeutic option to women in advanced stages of their disease with limited treatment options."Back To Top
Fast Track Designation Given to STRO-002 for Patients with Advanced Ovarian Cancer. Appl Rad Oncol.