Dr. Tagawa on the FDA Approval of Sacituzumab Govitecan in Advanced Urothelial Carcinoma

Scott T. Tagawa, MD, MS, FACP, professor of medicine and urology, Weill Cornell Medical College, attending physician, NewYork-Presbyterian Hospital, medical director, Genitourinary Oncology Research Program, Weill Cornell Medicine, discusses the FDA approval of sacituzumab govitecan-hziy (Trodelvy) in advanced urothelial carcinoma.

On April 13, 2021, the FDA granted an accelerated approval to sacituzumab govitecan for the treatment of patients with locally advanced or metastatic urothelial carcinoma who previously received a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.

The regulatory decision was based on findings from the phase 2 TROPHY-U-01 trial (IMMU-132-06; NCT03547973), in which treatment with the antibody-drug conjugate led to a confirmed objective response rate of 27.7% in this patient population.

Cohort 1 of the TROPHY-U-01 trial enrolled 113 patients with metastatic urothelial carcinoma who progressed on previous platinum-based therapy and at least 1 checkpoint inhibitor, says Tagawa. Evaluable patients received a median number of 3 prior therapies.

Although other treatment options are available for patients in this setting, they don’t always confer significant or prolonged benefit for patients, says Tagawa. As such, having sacituzumab govitecan as another option is welcome for this patient population, Tagawa adds.