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The FDA has accepted the supplemental Biologics License Application (sBLA) for durvalumab for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy and granted priority review status. Durvalumab is a human monoclonal antibody directed against PD-L1, which blocks the interaction of PD-L1 with PD-1 and CD80.

FDA; non-small cell ... - Click to enlarge in new windowFDA; non-small cell lung cancer. FDA; non-small cell lung cancer

The sBLA submission acceptance is an important milestone for durvalumab in a disease state where patients need better treatment options and outcomes. Currently, the standard of care for these patients with locally advanced (stage III) lung cancer is active monitoring following definitive chemoradiation.


The submission is based on positive progression-free survival data from the phase III PACIFIC trial. The trial continues to evaluate overall survival, its other primary endpoint. Detailed results of the PACIFIC trial, including additional safety information, were published in the New England Journal of Medicine (2017; doi:10.1056/NEJMoa1709937).


On Sept. 28, 2017, the NCCN Clinical Practice Guidelines in Oncology were updated to include durvalumab for the treatment of patients with locally advanced, unresectable NSCLC with no disease progression after two or more cycles of definitive chemoradiation, based on the data from the PACIFIC phase III trial. This indication is not yet FDA-approved.


Durvalumab has already received accelerated approval in the U.S. for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before or after surgery.