Roche Withdraws Bladder-Cancer Indication for Tecentriq in US
March 08 2021 - 1:59AM
Dow Jones News
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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