On October 18, Gilead Sciences announced its plans to voluntarily withdraw the U.S. accelerated approval for sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and PD-1 or PD-L1 inhibitor. This decision was made in consultation with the U.S. Food and Drug Administration (FDA) and does not affect the other approved indications for the treatment.
Sacituzumab govitecan, a TROP-2–directed antibody-drug conjugate, was granted accelerated approval for metastatic urothelial cancer in 2021 based on tumor response rate and duration of response data from cohort 1 of the global phase II, single-arm TROPHY-U-01 study. Continued approval for this indication was contingent on verification and description of clinical benefit in the confirmatory TROPiCS-04 study. Earlier this year, Gilead announced that the TROPiCS-04 study did not meet the primary endpoint of overall survival in the intention-to-treat population. These data will be presented at an upcoming medical meeting.
Health-care providers will be notified of this update. Patients receiving sacituzumab govitecan for metastatic urothelial cancer in the United States should discuss their care with their health-care provider.
