Durvalumab Granted Breakthrough Therapy Designation in Locally Advanced Lung Cancer
Posted: Monday, July 31, 2017
Today, durvalumab (Imfinzi) was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) 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. This announcement was made by AstraZeneca and MedImmune (AstraZeneca’s global biologics research and development arm).
The Breakthrough Therapy designation for durvalumab in this patient population was based on the 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 who had 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.
Durvalumab is being tested in other lung cancer studies, such as in the adjuvant NSCLC setting in the ADJUVANT phase III trial and in the first-line setting as monotherapy and in combination with tremelimumab in the MYSTIC, NEPTUNE, and PEARL phase III trials.