Posted by Michael Wonder on 09 Oct 2017
The European Medicines Agency accepts marketing authorisation application for Imfinzi in locally-advanced unresectable non-small cell lung cancer
9 October 2017 - AstraZeneca, along with MedImmune, its global biologics research and development arm, has announced that the EMA has accepted a marketing authorisation 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.
This is the first registrational submission for Imfinzi in the European Union.
The 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.
