BETHESDA, Md., May 19 (UPI) -- The U.S. Food and Drug Administration approved an immunotherapy drug for bladder cancer, making available the fourth drug on the market that shrinks or kills tumors by turning the immune system against cancer cells.
Tecentriq gained FDA approval for the most common type of bladder cancer, urothelial carcinoma, after being given a breakthrough therapy designation, priority review status and an accelerated approval based on its effects clinical trials.
Immunotherapy drugs for cancer target the PD-1 and PD-L1 pathways on immune cells and some cancer cells, the blocking of which helps the immune system fight cancer cells.
Other immunotherapy drugs targeting the same cell pathways -- Opdivo, for melanoma, lung cancer and kidney cancer, Keytruda, for metastatic melanoma, and Yervoy, for melanoma -- have been shown in trials to be more effective than standard therapies.
"Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a press release. "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 is the first of the drugs approved for bladder cancer, and also the first targeting the PD-L1 pathway.
In a single-arm clinical trial, 310 patients with urothelial carcinoma were treated with Tecentriq after other therapies had not been effective against their cancer.
Overall, 14.8 percent of patients saw their tumors shrink for 2.1 to 13.8 months. Of patients with high levels the PD-L1 protein on tumor cells, 26 percent saw a response from their tumor, as did 9.5 percent of patients whose tumors were not high in the protein.
"Even though bladder cancer is the fifth most commonly diagnosed cancer in the United States, it hasn't received the same attention within the cancer community as other common cancers," Diane Zipursky Quale, president of the Bladder Cancer Advocacy Network, said in a press release. "TECENTRIQ is a new medicine for people whose locally advanced or metastatic bladder cancer has progressed on platinum-based chemotherapy and may have limited treatment options."