FDA Grants Tecentriq Accelerated Approval as Initial Treatment for Certain People with Advanced Bladder Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq® (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy.  The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit.

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Bladder cancer is the most common type of urothelial carcinoma, and up to half of all people with the advanced form of the disease are unable to receive cisplatin chemotherapy as an initial treatment and therefore have a high unmet medical need. Urothelial carcinoma also includes cancers of the urethra, ureters and renal pelvis.  According to the American Cancer Society (ACS), it is estimated that more than 79,000 Americans will be diagnosed in 2017 with bladder cancer, which is the most common type of urothelial cancer.

About Tecentriq®

Tecentriq® is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq® is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq® may enable the activation of T cells.

About the IMvigor210 study

IMvigor210 is clinical trial that evaluated the safety and effectiveness of Tecentriq® in people with locally advanced or mUC, regardless of PD-L1 expression. People in the study were enrolled into one of two groups. The accelerated approval is based on results from a group of 119 people with locally advanced or mUC who were ineligible for cisplatin-containing chemotherapy and were either previously untreated or had disease progression at least 12 months after chemotherapy.  Tecentriq® was well tolerated and active in treating individuals that did or did not express PD-1. Overall response rates approaching 22% – 28%% were achieved in both groups.

Reference: http://www.roche.com/media/store/releases/med-cor-2017-04-18.htm

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