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.
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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.
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(END) Dow Jones Newswires
December 18, 2017 02:40 ET (07:40 GMT)