FDAnews
www.fdanews.com/articles/201764-roche-withdraws-tecentriqs-approval-for-bladder-cancer
Withdraws cubes

Roche Withdraws Tecentriq’s Approval for Bladder Cancer

March 10, 2021

Roche is withdrawing the U.S. indication for its immunotherapy Tecentriq (atezolizumab) used for treatment of urothelial carcinoma in patients who received prior platinum-based chemotherapy.

The drug received Accelerated Approval in 2016 for the indication but failed to meet its primary endpoint of overall survival in a follow-up study.

While the withdrawal is disappointing, Tecentriq “continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients,” said Levi Garraway, Roche’s chief medical officer and head of global product development.

View today's stories