Imfinzi closer to market in LS-SCLC

AstraZeneca’s (LSE: AZN) supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review by the US Food and Drug Administration (FDA).

This sBLA is based on the results from the positive ADRIATIC Phase III trial in patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based concurrent chemoradiotherapy.

The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is anticipated during the fourth quarter of this year.