AstraZeneca Granted US Priority Review for Early-Stage Lung Cancer Adjuvant Drug
20 Oktober 2020 - 8:53AM
Dow Jones News
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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