ZURICH () – Roche is withdrawing its immune protection against Tecentriq cancer from the US to treat metastatic urothelial cancer or platinum-treated urinary cancer, the Swiss drugmaker said on Monday, after subsequent trials failed to meet targets.
“This decision was made in agreement with the US Food and Drug Administration (FDA) as part of an industry review of accelerated inspections with confirmatory tests that did not meet their primary endpoints and have yet to receive regular approvals,” Roche said in a statement.
Roche initially won an accelerated burglary from the FDA for Tecentriq in people previously treated for the most common form of bladder cancer, the first indication of immunotherapy, but needed to gather follow-up data to get a regular burglary.
The problems, however, emerged quickly, as Roche said in 2017 that Tecentriq showed no benefit for survival in second-line bladder cancer, questioning whether the FDA should reverse the accelerated burglary.
The withdrawal of the Basel-based company on Monday does not affect other proven indications of Tecentriq, including non-small cell lung cancer, small cell lung cancer, certain types of bladder cancer, triple-negative breast cancer and hepatocellular carcinoma, or liver cancer, in a number of jurisdictions.