FDA grants fast track designation to STRO-002 for advanced gynecologic cancers
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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.
STRO-002 (Sutro Biopharma) is a folate receptor alpha-targeting antibody-drug conjugate.
The phase 1 STRO-001-GM1 trial is assessing STRO-002 for women with advanced ovarian cancer that progressed or relapsed after standard treatments.
A dose-escalation cohort has been completed; enrollment is underway in the U.S. and Spain for a dose-expansion cohort. Women will be randomly assigned 1:1 to STRO-002 dosed at 4.3 mg/kg or 5.2 mg/kg every 3 weeks.
Researchers will not preselect women for folate receptor alpha expression; however, women will be required to provide tissue samples for analysis prior to study treatment.
“Receiving fast track designation is an important recognition for STRO-002 as a potentially best-in-class folate receptor alpha [antibody-drug conjugate] for women with ovarian cancer,” Bill Newell, CEO of Sutro Biopharma, said in a company-issued 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.”
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