Atezolizumab No Longer Available in US for a Certain Type of Bladder Cancer

The U.S. indication for atezolizumab (Tecentriq) to treat patients with previously untreated locally advanced or metastatic urothelial carcinoma — a type of bladder cancer — has been voluntarily withdrawn by the agent’s manufacturer, Roche, after consulting with the FDA.¹

According to Roche, this withdrawal does not affect other FDA-approved indications for atezolizumab in the U.S.

The withdrawal was made in accordance with the FDA’s Accelerated Approval program after results from the phase 3 IMvigor130 trial (NCT02807636) failed to meet the postmarketing requirement necessary to convert the accelerated approval for atezolizumab into regular approval.

In the trial, atezolizumab plus chemotherapy did not reach the co-primary end point of improved overall survival (OS) compared with chemotherapy alone in the treatment of patients with previously untreated advanced bladder cancer.

“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval program, which brings innovative medicines to patients sooner,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Roche, said regarding the decision. “We remain confident in the benefit [atezolizumab] offers to people diagnosed with some of the most difficult-to-treat forms of cancer. There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for [OS].”

Previously, the FDA’s Oncologic Drugs Advisory Committee voted 10-to-1 in favor of upholding the accelerated approval of atezolizumab in the treatment of patients with metastatic urothelial carcinoma in April 2021.² This accelerated approval was originally granted in 2017 based on findings from the phase 2 IMvigor210 trial (NCT02108652), which demonstrated that atezolizumab produced promising responses in patients regardless of PD-L1 expression status.³

The FDA then updated this indication to include patients with high PD-L1 expression based on data from the IMvigor130 trial in 2018.

References

1. Genentech provides update on Tecentriq U.S indication for previously untreated metastatic bladder cancer. News release. Genentech. November 28, 2022. Accessed November 28, 2022. bit.ly/3GW6GLU
2. FDA Advisory Committee votes in favor of maintaining accelerated approval of Genentech’s Tecentriq for previously untreated metastatic bladder cancer. News release. Genentech. April 28, 2021. Accessed November 28, 2022. https://bit.ly/3eENQcn
3. FDA grants Roche’s TECENTRIQ® (atezolizumab) accelerated approval as initial treatment for certain people with advanced bladder cancer. News release. Roche. April 18, 2017. Accessed November 28, 2022. https://bit.ly/3t5fS5T