Gilead Withdraws US Indication for Sacituzumab Govitecan in Metastatic Urothelial Cancer

Withdrawal of Indication:
Gilead Sciences has voluntarily withdrawn the US indication for sacituzumab govitecan-hziy (Trodelvy) in the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.

Reason for Withdrawal:
The decision was made after the confirmatory phase 3 TROPiCS-04 study failed to meet its primary endpoint of overall survival (OS) in the intention-to-treat population. Although there was a numerical improvement in OS, it was not statistically significant.

Impact on Other Indications:
This withdrawal does not affect other approved indications for Trodelvy in the US or internationally, including its use in triple-negative breast cancer and hormone receptor-positive, HER2-negative breast cancer.

Background:
Sacituzumab govitecan was granted accelerated approval in 2021 based on data from the phase 2 TROPHY-U-01 study. The TROPiCS-04 study was intended to confirm the clinical benefit but did not meet its primary endpoint.

Safety Concerns:
The TROPiCS-04 study also showed a higher rate of adverse effects leading to death in the sacituzumab govitecan arm, primarily related to neutropenic complications.

Future Plans:
Full data from the TROPiCS-04 study will be presented at an upcoming medical conference. Gilead is further investigating the data, particularly the subgroup analyses and safety concerns.