First New Bladder Cancer Drug in 30 Years Receives FDA Approval

Although bladder cancer is the fifth most common cancer, no new treatments have become available in the last 30 years. That changed on Wednesday, May 18, 2016 when the FDA granted approval to Genentech’s Tecentriq.

Tecentriq is Genentech’s brand name for atezolizumab, the drug that received accelerated approval from the U.S. Food and Drug Administration for treatment of advanced cases of the most common type of bladder cancer, urothelial carcinoma. Urothelial carcinoma can be found in other structures of the urinary system, in addition to or instead of, the bladder.

Tecentriq is a cancer immunotherapy, a PD-L1 inhibitor, rather than a chemotherapy agent. Where chemotherapy drugs destroy both cancerous and healthy cells, immunotherapy agents such as Tecentriq aid the body’s immune system first to identify the cancer cells then to destroy those unhealthy cells.

In the clinical trials using atezolizumab for the treatment of advanced localized or metastatic urothelial cancer, it was found that patients who tested positive for the expression of the PD-L1 protein in their tumors demonstrated a positive response to the drug at a rate nearly three times greater than patients whose tumors tested negative for the expression of PD-L1 (26 percent compared to 9.6 percent).

Overall, 14.8 percent of the clinical trial participants experienced at least a partial shrinkage of their tumors, which lasted from slightly over 2 months to nearly 14 months at the time the trial’s analysis was completed. The FDA approved Tecentriq through an accelerated process, labeling it a breakthrough drug. It is one of many PD-1/PD-L1 targeted biologics class of medications approved by the federal agency since 2013.

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products within the FDA’s Center for Drug Evaluation and Research released a statement about Tecentriq specifically and the PD-1/PD-L1 agents in general, “Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway. 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 expected to be available in the United States within one to two weeks at an estimated price of $12,500 per month. Genentech, a subsidiary of the Roche Group, has plans to provide financial assistance to qualifying patients, according to company spokeswoman Emmy Wang.

Additional clinical trials are underway to determine the effectiveness of atezolizumab in the treatment of additional types of cancer.

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