By Jaime Llinares Taboada

 

AstraZeneca PLC said Tuesday that its Tagrisso adjuvant therapy for patients with early-stage, epidermal growth factor receptor-mutated, non-small cell lung cancer has been granted priority review in the U.S.

The FTSE 100 pharmaceutical giant said treatment with Tagrisso reduced the risk of disease recurrence or death by 80% in the Phase 3 trial, which involved tests on 682 patients across 20 countries.

"Patients with early-stage EGFR-mutated lung cancer are still at considerable risk of recurrence after surgery and adjuvant chemotherapy, and new targeted treatment options are critical to improving outcomes for these patients," said Dave Fredrickson, executive vice president of AstraZeneca's oncology division.

The U.S. Food and Drug Administration grants priority review to those drugs that offer significant improvements over available options. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is set to be in the first quarter of 2021.

 

Write to Jaime Llinares Taboada at jaime.llinares@wsj.com; @JaimeLlinaresT

 

(END) Dow Jones Newswires

October 20, 2020 02:38 ET (06:38 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.
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