07:09 AM EDT, 06/10/2024 (MT Newswires) -- AstraZeneca ( AZN ) said Monday that its supplemental new drug application for Tagrisso has been accepted and granted priority review in the US for the treatment of adult patients with unresectable, stage III epidermal growth factor receptor-mutated non-small cell lung cancer after chemoradiotherapy.

The Food and Drug Administration action date for a regulatory decision is anticipated during Q4. If approved, Tagrisso will be indicated for patients whose tumors have exon 19 deletions or exon 21 mutations, the company said.

The supplemental new drug application is based on data from the LAURA phase III trial, which extended median progression-free survival by more than three years.

In the trial, Tagrisso reduced the risk of disease progression or death by 84% compared to placebo as assessed by a blinded independent central review, the company said.

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