07:58 AM EDT, 08/15/2024 (MT Newswires) -- AstraZeneca ( AZN ) said Thursday that its supplemental biologics license application for IMFINZI has been accepted and granted priority review in the US.

The Food and Drug Administration's action date for their regulatory decision is expected during Q4.

The company said the application was based on positive results from the ADRIATIC phase III trial in patients with limited-stage small-cell lung cancer whose disease has not progressed following chemoradiotherapy. IMFINZI reduced the risk of death by 27% versus placebo in the trial.

IMFINZI was also recently granted breakthrough therapy designation by the FDA, which accelerates the development and regulatory review of potential new medicines to treat a serious condition and address a significant unmet medical need, the company said.

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