Gilead Sciences

Trodelvy indication for urothelial cancer to be withdrawn

October 22, 2024

On October 18, 2024, Gilead Sciences announced plans to voluntarily withdraw the U.S. accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with locally advanced or metastatic urothelial cancer who’ve previously received a platinum-containing chemotherapy and either PD-1 or PD-L1 inhibitor. According to a press release, the decision was made in consultation with the FDA.

Trodelvy was granted accelerated approval for metastatic urothelial cancer in 2021 based on tumor response rate and duration of response data from the phase 2, single-arm TROPHY-U-01 study. Continued approval for this indication was contingent on confirmation of clinical benefit in the TROPiCS-04 study. However, the TROPiCS-04 study didn’t meet the primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population.

The company said the decision doesn’t affect the other approved Trodelvy indications within or outside of the U.S.

Source:

Gilead Sciences. (2024, October 18). Gilead provides update on U.S. indication for Trodelvy® in metastatic urothelial cancer. [Press release]. https://www.gilead.com/company/company-statements/2024/gilead-provides-update-on-us-indication-for-trodelvy-in-metastatic-urothelial-cancer