US Pharm. 2016;41(6):10.
Silver Spring, MD—The FDA has approved atezolizumab (Tecentriq) for the treatment of urothelial carcinoma, the most common type of bladder cancer. This is the first PD-L1 inhibitor to be granted approval and the latest in the broader class of PD-1/PD-L1 biologics authorized by the FDA in the last 2 years, which use immunotherapy to target cancer cells. The safety and efficacy of atezolizumab were studied in a single-arm clinical trial involving 310 patients with locally advanced or metastatic urothelial carcinoma. The results showed that 14.8% of patients experienced at least a partial shrinkage of their tumors. The agent, which will be marketed by Genentech, had been granted a breakthrough therapy designation, priority review status, and accelerated approval for this indication.
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