Genentech has voluntarily withdrawn the US indication of atezolizumab for the treatment of patients with metastatic urothelial cancer previously treated with platinum-based therapies, according to a press release issued by the company.

Atezolizumab, an intravenously administered monoclonal antibody, received accelerated approval from the US Food and Drug Administration (FDA), which provides conditional approval to therapies that fulfill a high unmet medical need. Sustained approval was contingent on results from the phase 2 IMvigor210 clinical trial.

The study failed to meet its primary endpoint of overall survival in a cohort of patients with locally advanced or metastatic bladder cancer that progressed after platinum-based therapy. IMvigor210 will remain the postmarketing study of record for atezolizumab until its final analysis.

Working in concert with the FDA, Genentech made the decision to voluntarily withdraw atezolizumab’s indication as part of an industry-wide review of therapies with confirmatory trials that did not meet their primary endpoints after receiving accelerated approval. The choice reflects advancements in the treatment landscape of metastatic urothelial cancer and the “emergence of new treatment options,” according to the press release.

Patients prescribed atezolizumab for this indication should discuss treatment options with their oncology provider.

“While the withdrawal of [atezolizumab] for prior-platinum treated bladder cancer is disappointing, [atezolizumab] continues to demonstrate benefits across multiple cancer types, and therefore remains a meaningful treatment option for many patients,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, in the press release.

The FDA will hold a public advisory committee meeting of the Oncologic Drugs Advisory Committee to discuss six therapies that received accelerated approval but whose confirmatory trials have yet to validate clinical benefit. 

“Based on the updates provided, the committee will have a general discussion focused on next steps for each product, including whether the indications should remain on the market while additional trials are conducted,” the agency said in a press release. 

The meeting will be held April 27-29, 2021. Due to the ongoing COVID-19 pandemic, all sessions will be conducted virtually.