FDA Accepts sBLA for Durvalumab in Locally Advanced Unresectable NSCLC

On October 17, the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for durvalumab (Imfinzi) for the treatment of patients with locally advanced (stage III) unresectable non–small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The FDA has granted durvalumab Priority Review status.

The sBLA submission acceptance is a milestone for durvalumab in a disease state where patients need better treatment options and outcomes. Currently, the standard of care for patients with this earlier stage of lung disease is active monitoring following concurrent chemoradiation.

The sBLA 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 online in The New England Journal of Medicine.

On September 28, 2017, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines©) 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 trial. This indication is not yet FDA-approved.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.