By Kim Richters

Roche Holding AG said Monday that it is voluntarily withdrawing the U.S. indication for Tecentriq in metastatic bladder cancer that previously received platinum-based therapy.

The Swiss pharmaceutical major said this was decided in consultation with the U.S. Food and Drug Administration, which was reviewing accelerated approvals across the industry.

Roche Holding AG said IMvigor211, the original confirmatory study for the accelerated approval, didn't meet its primary endpoint. Tecentriq had been granted that approval in 2016 based on the results from the IMvigor210 study.

"While 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," Roche's Chief Medical Officer Levi Garraway said.

Other approved indications for the drug aren't affected, the company said.

Write to Kim Richters at kim.richters@wsj.com

Corrections & Amplifications

This was corrected March 9, 2021 because the original version incorrectly said the IMvigor210 study didn't meet its primary endpoint.

(END) Dow Jones Newswires

03-08-21 0144ET