SILVER SPRING, Md., May 18, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Tecentriq (atezolizumab) to treat the most common type of bladder cancer, called urothelial carcinoma. This is the first product in its class (PD-1/PD-L1 inhibitors) approved to treat this type of cancer.

"Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Products that block PD-1/PD-L1 interactions are part of an evolving story about the relationship between the body's immune system and its interaction with cancer cells."

Tecentriq targets the PD-1/PD-L1 pathway (proteins found on the body's immune cells and some cancer cells). By blocking these interactions, Tecentriq may help the body's immune system fight cancer cells. Tecentriq is the first FDA-approved PD-L1 inhibitor and the latest in the broader class of PD-1/PD-L1 targeted biologics approved by the FDA in the last two years.
Tecentriq is approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical treatment. Urothelial carcinoma is the most common type of bladder cancer and occurs in the urinary tract system, involving the bladder and related organs. The National Cancer Institute (NCI) estimates 76,960 new cases of bladder cancer and 16,390 deaths from the disease in 2016.

The safety and efficacy of Tecentriq were studied in a single-arm clinical trial involving 310 patients with locally advanced or metastatic urothelial carcinoma. This trial measured the percentage of patients who experienced complete or partial shrinkage of their tumors (objective response rate). The study also looked at the difference in effect based on "positive" versus "negative" expression of the PD-L1 protein on patients' tumor-infiltrating immune cells. In all patients, 14.8 percent of participants experienced at least a partial shrinkage of their tumors, an effect that lasted from more than 2.1 to more than 13.8 months at the time of the response analysis. In patients who were classified as "positive" for PD-L1 expression, 26 percent of participants experienced a tumor response (compared to 9.5 percent of participants who were classified as "negative" for PD-L1 expression).

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