FDA Grants Accelerated Approval To Gilead Sciences' Trodelvy For Treatment Of Urothelial Cancer

(RTTNews) - Gilead Sciences Inc. (GILD) Tuesday announced that the U.S. Food and Drug Administration has granted accelerated approval of Trodelvy for use in patients with locally advanced or metastatic urothelial cancer.

The accelerated approval was based on data from the international Phase 2, single-arm TROPHY study.

Of the 112 patients who were evaluable for efficacy, 27.7% of those treated with Trodelvy responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response.

The FDA's accelerated approval mechanism enables drugs that treat serious diseases with unmet medical need to be approved based on a surrogate or intermediate clinical endpoint.

"Only a fraction of patients derives long-term benefit from previously approved cytotoxic therapy or immunotherapy, leaving a great unmet need for treatment options for patients with advanced urothelial cancer who have progressed on first- and second-line therapies," said Scott Tagawa, MD, MS, FACP, Professor of Medicine and Urology at Weill Cornell Medicine, an oncologist at New York-Presbyterian/Weill Cornell Medical Center and principal investigator of the TROPHY study.