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The FDA approved atezolizumab (Tecentriq) for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on a targeted therapy if their tumor has EGFR or ALK gene abnormalities.

  
FDA; Atezolizumab. F... - Click to enlarge in new windowFDA; Atezolizumab. FDA; Atezolizumab

This approval is based on results from the randomized phase III OAK and phase II POPLAR studies. The largest study, OAK, showed that atezolizumab helped people in the study live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR=0.74, 95% CI: 0.63, 0.87). The study enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.

 

The atezolizumab development program includes more than 15 clinical trials in lung cancer, including seven phase III studies in previously untreated lung cancer. These studies are evaluating the use of atezolizumab alone or in combination with other medicines.