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


Roche Holding AG (OTCMKT: 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.

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Posted-In: bladder cancerBiotech News Health Care FDA General

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