AstraZeneca's Tagrisso gets FDA priority review in lung cancer subtype
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The U.S. Food and Drug Administration (FDA) granted priority review to AstraZeneca's (NASDAQ:AZN) application seeking expanded approval of Tagrisso to treat certain patients with a type of non-small cell lung cancer (NSCLC).
The British pharma giant's supplemental new drug application (sNDA) is for Tagrisso (osimertinib), in combination with chemotherapy, to treat adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) NSCLC.
The FDA is expected to make a decision during Q1 2024. Under a priority review the FDA's goal is to take action on an application within 6 months, compared to 10 months under standard review.
The sNDA is backed by data from a phase 3 trial called FLAURA2.
"The FLAURA2 results reinforce TAGRISSO as a backbone of standard of care in 1st-line EGFR-mutated non-small cell lung cancer, providing patients with an additional nine months of median progression-free survival when combined with chemotherapy," said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca (AZN).
In August, the Tagrisso combo had received the FDA's breakthrough therapy designation in this setting for the first-line treatment of adult patients with locally advanced or metastatic EGFRm NSCLC.

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