AstraZeneca Says FDA Granted Priority Review For Imfinzi In Limited-stage Small Cell Lung Cancer

(RTTNews) - AstraZeneca PLC (AZN.L) Thursday said the Food and Drug Administration (FDA) has granted priority review for its supplemental biologics license application (sBLA) for Imfinzi to treat patients with limited-stage small cell lung cancer (LS-SCLC).

The Prescription Drug User Fee Act date, the date on which a decision from the regulator is expected, is set during the fourth quarter of 2024.

The sBLA for Imfinzi was based on positive data from ADRIATIC Phase III trial in patients with LS-SCLC whose disease has not progressed following platinum-based concurrent chemoradiotherapy.

Imfinzi has already been granted breakthrough therapy designation by the FDA in this setting.