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News From the Food and Drug Administration
July 5, 2016

New Bladder Cancer Drug

Author Affiliations

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;316(1):24. doi:10.1001/jama.2016.8071

The FDA has approved atezolizumab to treat urothelial carcinoma, the most common type of bladder cancer. Marketed as Tecentriq, the drug is the first PD-1/PD-L1 inhibitor, a form of immunotherapy, approved to treat bladder cancer.

Atezolizumab’s safety and efficacy were studied in a single-group trial with 310 patients who had locally advanced or metastatic urothelial carcinoma. About 15% of the patients treated had at least partial shrinkage of their tumors lasting from 2 to 14 months. Among patients who had high levels of PD-L1 protein expression, 26% experienced some tumor shrinkage compared with 9.5% who had low levels of PD-L1 expressed (

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