AstraZeneca and MedImmune, its global biologics research and development arm, got clearance from the FDA to have Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT).
Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: “The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy. Globally, approximately 30% of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting.”
Scott J. Antonia, Chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center said that so far the treatment guidelines have recommended that patients with unresectable Stage III lung cancer undergo a period of active surveillance following chemoradiation therapy until disease progression. “The PACIFIC trial data supporting today’s approval of Imfinzi will change how we treat these patients.”