AstraZeneca Says Tagrisso Supplemental NDA Accepted by FDA

By Dimitrios Kontos Features Dow Jones Newswires

AstraZeneca PLC (AZN.LN) said Monday that the U.S. Food and Drug Administration has accepted a supplemental new drug application for Tagrisso.

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The supplemental application is for the use of the drug in the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have mutations, the company said.

AstraZeneca said the FDA has granted Tagrisso priority review status based on data from a phase 3 trial which showed that the drug improved survival in previously untreated patients.

The FDA has previously granted Tagrisso a breakthrough therapy designation in the first-line treatment of patients with metastatic EGFR mutation-positive non-small cell lung cancer, the company said.

Write to Dimitrios Kontos at dimitrios.kontos@dowjones.com

(END) Dow Jones Newswires

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December 18, 2017 02:40 ET (07:40 GMT)