FDA Grants Fast Track Designation to STRO-002 for Advanced Ovarian Cancer

STRO-002 is a folate receptor alpha-targeting antibody drug conjugate for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior lines of systemic therapy.

Sutro Biopharma has been granted FDA Fast Track Designation for STRO-002, a folate receptor alpha-targeting antibody drug conjugate indicated for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 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 Arturo Molina, MD, MS, chief medical officer at Sutro Biopharma, in a press release. “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.”

The drug is being investigated in the STRO-001-GM1 phase 1 clinical trial of patients with advanced ovarian cancer that has progressed or relapsed following standard of care treatments. The dose-escalation cohort has been completed and the dose-expansion cohort is continuing to enroll patients from the United States and Spain, according to a Sutro Biopharma press release.

In the trial, patients are not pre-selected for folate receptor alpha-targeting expression but are required to provide a tissue sample for analysis prior to treatment. Participants are then randomized 1:1 and treated with STRO-002 at either 4.3 or 5.3 mg/kg every 3 weeks.

“Receiving Fast Track Designation is an important recognition for STRO-002 as a potentially best-in-class [folate receptor alpha-targeting antibody drug conjugate] for women with ovarian cancer,” said Bill Newell, JD, chief executive officer of Sutro Biopharma, in the press release. “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.”

REFERENCE

Sutro Biopharma Announces STRO-002 FDA Fast Track Designation for Patients with Advanced Ovarian Cancer. News release. Sutro Biopharma; August 18, 2021. Accessed August 19, 2021. https://www.sutrobio.com/sutro-biopharma-announces-stro-002-fda-fast-track-designation-for-patients-with-advanced-ovarian-cancer/