The U.S. Food and Drug Administration approved an immunotherapy developed by Roche for the treatment of advanced cases of urothelial carcinoma. Urothelial carcinoma is a bladder cancer.
According to the American Cancer Society, there are expected to be about 77,000 new cases of bladder cancer this year in the United State and 16,000 deaths. About three-quarters are in men, making bladder cancer the fourth most common cancer in men.
Bladder cancer is treated with surgery, chemotherapy and radiation, although those are not very effective once the cancer is in advanced stages.
The therapy, called Tecentriq, works by preventing a protein called PD-L1 from binding to the PD-1 protein on T cells and inhibiting the body’s immune response.
Tecentriq is the fourth checkpoint inhibitor to be approved. Other checkpoint inhibitors inhibit the same immune interaction but do so by binding to PD-1, whereas Tecentriq binds to PD-L1.
This is the first checkpoint inhibitor approved for bladder cancer.
In a clinical study, 14.8& of patients had their tumors shrink significantly following treatment. In 5.5%, the cancer disappeared completely.
According to The Wall Street Journal, the treatment will cost about $12,500 a month.
The U.S. Food and Drug Administration also approved an accompanying diagnostic that measures PD-L1 levels in order to asses a patient’s likelihood of responding to Tecentriq. Patients with high PD-L1 had the most success on the therapy. Tumors shrunk in about 26% of patients and 12% of patients experienced complete remissions.
However, it is unclear how much of an impact immunotherapy will have on bladder cancer since patients have not been followed for a long time. Regardless, the U.S. Food and Drug Administration found Roche’s data compelling enough and the need urgent enough to approve Tecentriq about four months ahead of the agency’s September 12 deadline.
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