AstraZeneca: TAGRISSO Plus Chemotherapy Granted Priority Review By FDA

(RTTNews) - AstraZeneca (AZN.L, AZN) said the supplemental New Drug Application for TAGRISSO in combination with chemotherapy has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer. The sNDA is based on data from the FLAURA2 Phase III trial.

In August 2023, TAGRISSO in combination with chemotherapy received Breakthrough Therapy Designation in this setting for the 1st-line treatment of adult patients with locally advanced or metastatic EGFRm NSCLC.

TAGRISSO is approved as monotherapy in more than 100 countries including in the US, EU, China and Japan.

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