FDA Grants Durvalumab Breakthrough Therapy Designation for Patients With Locally Advanced Unresectable NSCLC

On July 31, AstraZeneca and MedImmune (AstraZeneca’s global biologics research and development arm) announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for durvalumab (Imfinzi) 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.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said, “For patients who have not progressed following chemoradiation therapy, the only current option is active monitoring. Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months. Durvalumab is the first immuno-oncology medicine to show a clinically significant benefit in this earlier, nonmetastatic setting, so following the Breakthrough Therapy designation, we hope to bring it to patients as soon as possible.”


The Breakthrough Therapy designation is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically significant endpoint over available medicines and when there is significant unmet medical need.

The Breakthrough Therapy Designation for durvalumab was granted on the basis of interim results from the phase III PACIFIC trial, a randomized, double-blinded, placebo-controlled multicenter trial of durvalumab as sequential treatment in patients with locally advanced, unresectable (stage III) NSCLC that has not progressed following standard platinum-based chemotherapy concurrent with radiation therapy. Data from the PACIFIC trial have been submitted for presentation at a forthcoming medical meeting.

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®.




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