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Roche Withdraws Tecentriq for Bladder Cancer After FDA Accelerated Approval Review

This article has been updated to note that atezolizumab is approved in the US for first-line metastatic bladder cancer and that the confirmatory study, IMvigor211, did not meet its primary endpoint rather than the IMvigor 210 trial as previously reported.

NEW YORK – Roche said on Monday it will withdraw the indication of atezolizumab (Tecentriq) in previously treated bladder cancer after a review of accelerated approvals by the US Food and Drug Administration.

Roche is voluntarily withdrawing the bladder cancer indication because the confirmatory study for the accelerated approval, IMvigor211, did not meet its primary endpoint in patients who were previously treated with platinum chemotherapy. As the treatment landscape for bladder cancer has advanced, atezolizumab does not fill an unmet medical need as required by the accelerated approval program, and Roche is "withdrawing this indication in recognition of the principles of the Accelerated Approval Program," the company said.

Atezolizumab was granted accelerated approval for bladder cancer by the FDA in 2016 based on results from the IMvigor210 trial. Full approval was contingent upon positive results from the IMvigor211 study, however, that trial showed the drug did not improve overall survival in the PD-L1-high patient population.

The FDA then designated the Phase III IMvigor130 trial evaluating atezolizumab plus chemotherapy versus placebo and chemotherapy as the post-marketing requirement to confirm the drug's clinical benefit in this patient group. Initial findings from IMvigor130 suggested that atezolizumab monotherapy may benefit bladder cancer patients with increased PD-L1 levels in their tumors. Despite the FDA withdrawal, the trial will continue until its final analysis, expected in 2022.

Atezolizumab is approved in the US for first-line metastatic bladder cancer, PD-L1-positive lung cancer, liver cancer, PD-L1-positive triple negative breast cancer, and BRAF V600 mutation-positive melanoma.