FDA moves ahead with review of Imfinzi label expansion

AstraZeneca has announced that the US FDA has accepted its application to extend the marketable use of Imfinzi (durvalumab), to include a new non-small cell lung cancer (NSCLC) patient population.

The application has been given priority review status, and is based on positive progression-free survival (PFS) data from the Phase III PACIFIC trial.

Detailed results of the trial, including safety information, were published in the New England Journal of Medicine.

Imfinzi is a checkpoint inhibitor currently being trialed in a broad range of oncology indications by AstraZeneca and its biologics arm, MedImmune.