AstraZeneca Says Tagrisso Supplemental NDA Accepted by FDA

By Dimitrios KontosFeaturesDow 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.

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.

Continue Reading Below

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

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