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Roche’s TECENTRIQ (Atezolizumab) Receives Priority Review

The new immunotherapy is being developed for the treatment of metastatic non-squamous non-small cell lung cancer.

According to the International Agency for Research on Cancer, lung cancer causes the most deaths on a global basis, killing nearly 1.6 million people each year. Non-squamous non-small cell lung cancer (NSCLC) is the most common form of the disease and accounts for over three quarters of all cases.

Cancer immunotherapies have attracted significant attention in recent years. These new treatments are designed to improve the effectiveness of the body’s immune system, increasing its ability to kill cancer cells.

One of these new drugs is Roche’s TECENTRIQ® (atezolizumab), a monoclonal antibody designed to bind to the protein PD-L1, which is expressed on tumor cells and tumour-infiltrating immune cells. Binding the protein prevents it from interacting with PD-1 and B7.1 receptors and thus enables the activation of T cells. It is intended to be used in combination with other cancer immunotherapies and established chemotherapies.

TECENTRIQ is already approved in the European Union, United States and more than 60 countries for people with previously treated metastatic NSCLC and for people with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy. It is currently being evaluated in eight different Phase 3 lung cancer studies, alone or in combination with other drugs.

The US Food and Drug Administration (FDA) recently accepted Roche’s supplemental Biologics License Application for TECENTRIQ in combination with Avastin® (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous NSCLC. The agency granted TECENTRIQ Priority Review and is expected to issue its decisions by early September 2018.

The FDA’s acceptance was based on results from Roche’s Phase 3 IMpower150 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with advanced non-squamous NSCLC.