(RxWiki News) The US Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) to treat urothelial carcinoma, the most common type of bladder cancer.
Tecentriq is part of a medication class called PD-1/PD-L1 inhibitors. These medications work to help the body’s immune system fight cancer cells. Tecentriq is the first product in this class to be approved to treat urothelial carcinoma.
Tecentriq is approved to treat urothelial carcinoma that has locally spread or has spread to other parts of the body. It is indicated for those patients whose cancer has progressed during or after platinum-containing chemotherapy, as well as within 12 months of treatment with platinum-containing chemotherapy and surgical treatment.
This approval means a potential new treatment option for many of the 76,960 new cases of bladder cancer the National Cancer Institute estimated will be diagnosed in 2016.
Genentech's Tecentriq received approval after trial data found that 14.8 percent of patients saw a partial shrinkage of their tumors. This response was found to last from more than 2.1 months to more than 13.8 months.
Furthermore, those who were found to be positive for PD-L1 proteins were found to have a better response to Tecentriq. That's why the FDA also approved the Ventana PD-L1 (SP142) assay. This assay detects PD-L1 protein expression levels and can therefore help health care providers identify those who may benefit more from receiving Tecentriq.
Common side effects were nausea, fatigue, decreased appetite, urinary tract infection, fever and constipation. Because this medication works with the immune system, there is a risk for developing infections and other serious side effects known as immune-mediated side effects.