Roche Walks Away From Regular FDA Nod For Tecentriq In Pretreated Bladder Cancer

Roche Holding AG RHHBF has joined AstraZeneca Plc (NASDAQ: AZN) in withdrawing cancer immunotherapies from the U.S. for bladder cancer that has already been treated with platinum-based chemotherapy, as confirmatory trials not meet their primary endpoints.

• The company decided to withdraw the U.S. indication for Tecentriq (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer).
• Tecentriq initially won accelerated FDA approval in 2016 for pre-treated people with this most common form of bladder cancer but was required to gather follow-up data to win regular approval.
• Roche said in 2017, Tecentriq failed to show a survival benefit in second-line bladder cancer.
• Other approved indications for Tecentriq include non-small cell lung cancer, small cell lung cancer, certain types of bladder cancer, triple-negative breast cancer, and liver cancer.
• Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1, which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. 
• Last month, AstraZeneca withdrew Imfinzi from the U.S. market for previously treated adult patients with locally advanced or metastatic bladder cancer.
• Price Action: RHHBF shares closed 3.1% lower at $328.50 on Friday.