Posted on June 8th, 2016 by
The United States Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) for the treatment of bladder cancer. Atezolizumab is an immunotherapy agent referred to as a PD-1/PD-L1 inhibitor, and is the first agent in this class to be approved for the treatment of bladder cancer.
Urothelial carcinoma (formerly known as transitional cell carcinoma) is a cancer involving parts of the kidney, bladder and ureter (the tube that connects the kidney to the bladder). Urothelial carcinomas begin in the cells that line the particular organ in which the cancer develops.
Urothelial carcinoma is the most common type of bladder cancer. If bladder cancer is detected and treated early, cure rates are high. However, once bladder cancer has spread outside of the bladder to distant sites in the body, effective treatment options remain limited, particularly if a patient experiences a cancer recurrence following prior therapies.
Atezolizumab is an agent that helps to restore the body’s immune system in fighting cancer. It creates its anti-cancer effects by blocking a specific protein that are used by cancer cells, called PD-L1, to escape an attack by the immune system. Once PD-L1 is blocked, cells of the immune system are able to identify cancer cells as a threat, and initiate an attack to destroy the cancer.
The approval is specifically for patients with urothelial carcinoma that has spread from its site of origin and has progressed despite prior therapy with a platinum agent (certain class of chemotherapy).
The FDA approved atezolizumab based upon results from a clinical trial that demonstrated a partial or complete disappearance of their cancer among patients with advanced urothelial cancer. Furthermore, patients who expressed higher levels of the PD-L1 protein experienced a greater anti-cancer response with atezolizumab than those who expressed lower PD-L1 levels.
The most common side effects of atezolizumab included fatigue, nausea and decreased appetite, urinary tract infection, constipation, and fever.
Within the FDA news release announcing the approval of atezolizumab, Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research stated that “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 provides these patients with a new therapy targeting the PD-L1 pathway.”
Reference: United States Food and Drug Administration. (2016.) News Release. FDA approves new, targeted treatment for bladder cancer. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm501762.htm. Accessed May 31, 2016.
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