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 received the accelerated approval for this indication in 2016 based on results from the IMvigor210 study. It now said the study didn't meet its primary endpoint and new treatment options had emerged.

"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

 

(END) Dow Jones Newswires

March 08, 2021 01:44 ET (06:44 GMT)

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