Posted by Michael Wonder on 17 Oct 2017
US FDA accepts supplemental biologics license application for Imfinzi in locally advanced unresectable non-small-cell lung cancer
17 October 2017 - Acceptance follows FDA’s breakthrough therapy designation.
AstraZeneca and MedImmune today announced that the US FDA has accepted a supplemental biologics license application for Imfinzi (durvalumab) for the treatment of patients with locally advanced (Stage III) unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy. The FDA has granted Imfinzi priority review status.
The US FDA submission acceptance is an important milestone for Imfinzi 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 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.
