Gilead Sciences' Trodelvy did not meet the main overall survival goal of its confirmatory Phase 3 test. The antibody drug conjugate was awarded accelerated approval for advanced urothelial carcinoma in 2021.
Tecentriq failed to beat chemotherapy in improving overall survival, the main goal of its confirmatory Phase 3 test in bladder cancer. The drug had been granted accelerated approval based on results from a single-arm Phase 2 clinical trial.
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Blockbuster Roche drug Tecentriq will be pulled from the U.S. market as a bladder cancer treatment—three years after failing clinical tests required to stay on the market. The voluntary withdrawal comes amid an industry-wide FDA review of drugs that were awarded accelerated approval but later failed confirmatory studies.
The drug was approved along with a companion diagnostic to detect alterations in FGFR2 and FGFR3. The drug is approved for patients with locally advanced or metastatic UC who carry those mutations.