Genentech withdraws Tecentriq indication for bladder cancer
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Genentech voluntarily withdrew atezolizumab’s indication in the United States for patients with platinum-treated metastatic urothelial carcinoma.
The company made the decision in consultation with FDA.
“[Although] the withdrawal of Tecentriq for prior platinum-treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and, therefore, remains a meaningful treatment option for many patients,” Levi Garraway, MD, PhD, chief medical officer and head of global product development with Genentech, said in a company-issued press release.
The FDA granted accelerated approval to atezolizumab (Tecentriq, Genentech) — an anti-PD-L1 monoclonal antibody — for this indication in 2016 based on results of the IMvigor210 study.
Continued approval was contingent on results of the phase 3 IMvigor211 trial; however, the study did not meet its primary endpoint of OS among the subgroup of patients with high PD-L1 expression.
The FDA subsequently designated the IMvigor130 study as the postmarketing requirement to confirm clinical benefit. Although IMvigor130 will continue until the final analysis, Genentech officials decided to withdraw the indication due to the emergence of new treatment options for prior platinum-treated metastatic urothelial carcinoma and “in recognition of the principles of the accelerated approval program,” the release stated.
Genentech’s decision does not affect other indications for atezolizumab. Aside from urothelial carcinoma, the agent is approved in the United States for treatment of certain patients with lung cancer, breast cancer, hepatocellular carcinoma and melanoma.
This is the fourth time in less than 3 months that a pharmaceutical company has voluntarily withdrawn a U.S. indication for a cancer therapy due to the failure of a confirmatory trial to achieve its primary endpoint.
The other indication withdrawals include pembrolizumab (Keytruda, Merck) for treatment of certain patients with metastatic small cell lung cancer; durvalumab (Imfinzi, AstraZeneca) for treatment of locally advanced or metastatic bladder cancer; and nivolumab (Opdivo, Bristol Myers Squibb) for treatment of certain patients with small cell lung cancer.
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