"The U.S. Food and Drug Administration today approved Tecentriq atezolizumab to treat the most common type of bladder cancer called urothelial carcinoma. This is the first product in its class PDPDL inhibitors approved to treat this type of cancer. Tecentriq provides these patients with a new therapy targeting the PDL pathway said Richard Pazdur M.D. director of the Office of Hematology and Oncology Products in the FDAs Center for Drug Evaluation and Research. Products that block PDPDL interactions are part of an evolving story about the relationship between the bodys immune system and its interaction with cancer cells.  Tecentriq targets the PDPDL pathway proteins found on the bodys immune cells and some cancer cells. By blocking these interactions Tecentriq may help the bodys immune system fight cancer cells. Tecentriq is the first FDAapproved PDL inhibitor and the latest in the broader class of PDPDL targeted biologics approved by the FDA in the last two years. Tecentriq is approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinumcontaining chemotherapy or within  months of receiving platinumcontaining chemotherapy either before neoadjuvant or after adjuvant surgical treatment. Urothelial carcinoma is the most common type of bladder cancer and occurs in the urinary tract system involving the bladder and related organs. The National Cancer Institute NCI estimates  new cases of bladder cancer and  deaths from the disease in . The safety and efficacy of Tecentriq were studied in a singlearm clinical trial involving  patients with locally advanced or metastatic urothelial carcinoma. This trial measured the percentage of patients who experienced complete or partial shrinkage of their tumors objective response rate. The study also looked at the difference in effect based on positive versus negative expression of the PDL protein on patients tumorinfiltrating immune cells. In all patients . percent of participants experienced at least a partial shrinkage of their tumors an effect that lasted from more than . to more than . months at the time of the response analysis. In patients who were classified as positive for PDL expression  percent of participants experienced a tumor response compared to . percent of participants who were classified as negative for PDL expression.  While patients who received Tecentriq experienced a tumor response across the study the greater effect in those who were classified as positive for PDL expression suggests that the level of PDL expression in tumorinfiltrating immune cells may help identify patients who are more likely to respond to treatment with Tecentriq. Therefore today the FDA also approved the Ventana PDL SP assay to detect PDL protein expression levels on patients tumorinfiltrating immune cells and help physicians determine which patients may benefit most from treatment with Tecentriq.  The most common side effects of treatment with Tencentriq were fatigue decreased appetite nausea urinary tract infection fever pyrexia and constipation. Tencentriq also has the potential to cause infection and serious side effects that result from the immune system effect of Tencentriq known as immunemediated side effects. These severe immunemediated side effects involve healthy organs including the lung colon and endocrine system.  The FDA granted the Tecentriq application breakthrough therapy designation http priority review status http and accelerated approval http for this indication. These are distinct programs intended to facilitate and expedite the development and review of certain new drugs in light of their potential to benefit patients with serious or lifethreatening conditions.  Tecentriq is marketed by Genentech based in San Francisco California. The Ventana PDL SP assay companion diagnostic for Tecentriq is marketed by Ventana Medical Systems based in Tucson Arizona.  For more information FDA Office of Hematology and Oncology Products http  FDA Approved Drugs Questions and Answers http  FDA Companion Diagnostics http  NCI Bladder Cancer http  The FDA an agency within the U.S. Department of Health and Human Services protects the public health by assuring the safety effectiveness and security of human and veterinary drugs vaccines and other biological products for human use and medical devices. The agency also is responsible for the safety and security of our nations food supply cosmetics dietary supplements products that give off electronic radiation and for regulating tobacco products. Media Inquiries Angela Stark  angela.starkfda.hhs.gov mailtoangela.starkfda.hhs.gov   Consumer Inquiries INFOFDA Logo  httpphotos.prnewswire.comprnhLOGO SOURCE U.S. Food and Drug Administration Related Links http"