Drugmaker Pulls Trodelvy’s Bladder Cancer Approval

Sacituzumab govitecan’s (Trodelvy) accelerated approval in urothelial cancer will be voluntarily withdrawn, Gilead Sciences announced on Friday.

The decision was made in consultation with the FDA and does not affect the antibody-drug conjugate’s other indications, the company said.

A Trop-2-directed antibody, sacituzumab govitecan was granted accelerated approval for urothelial cancer in 2021 — for patients with locally advanced or metastatic disease previously treated with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor — based on overall response rate (27%) and duration of response (median 5.9 months) data from the phase II TROPHY-U-01 trial.

Continued approval was contingent on demonstration of clinical benefit in a confirmatory trial.

But in the phase III TROPiCS-04 trial, sacituzumab govitecan in a similar patient population failed to improve overall survival (OS) versus single-agent chemotherapy (physician’s choice of paclitaxel, docetaxel, or vinflunine). Despite a numerical improvement in OS that favored sacituzumab govitecan, according to Gilead, deaths due to adverse events were higher with the Trop-2-directed antibody — mostly neutropenic complications early in treatment. Data from TROPiCS-04 will be presented at a future medical meeting.

Sacituzumab govitecan carries traditional approval for previously treated locally advanced or metastatic breast cancer, where the drug has demonstrated an OS benefit: both in triple-negative disease and hormone receptor-positive/HER2-negative disease.