ZURICH (Reuters) – Roche is withdrawing its cancer immunotherapy Tecentriq from U.S. use in treating prior-platinum treated metastatic urothelial carcinoma, or bladder cancer, the Swiss drugmaker said Monday, after follow-up trials failed to meet goals.
“This decision was made in consultation with the U.S. Food and Drug Administration (FDA) as part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals,” Roche said in a statement.
Roche initially won accelerated approval from the FDA in 2016 for Tecentriq in people previously treated for the most common form of bladder cancer, the immunotherapy’s first indication, but was required to gather follow-up data in order to win regular approval.
Problems emerged quickly, however, as Roche said in 2017 that Tecentriq failed to show a survival benefit in second-line bladder cancer, raising questions over whether the FDA should reverse the accelerated approval.
The withdrawal by the Basel-based company on Monday does not impact Tecentriq’s other approved indications, including non-small cell lung cancer, small cell lung cancer, certain types of bladder cancer, a kind of triple negative breast cancer and for hepatocellular carcinoma, or liver cancer, in numerous jurisdictions.
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