FDA Grants Priority Review to Durvalumab for Locally Advanced Unresectable NSCLC

October 17, 2017 – The FDA has granted a priority review to a supplemental biologics license application (sBLA) for durvalumab for the treatment of patients with stage III, unresectable non–small cell lung cancer (NSCLC), based on positive progression-free survival (PFS) results from the PACIFIC trial. The sBLA filed by AstraZeneca and MedImmune, the developers of durvalumab, is seeking approval for treatment of patients whose disease has not progressed following … (leggi tutto)