By Adria Calatayud
AstraZeneca PLC said Thursday that its Tagrisso drug has been granted breakthrough therapy designation in the U.S. for patients with non-small cell lung cancer.
The designation from the U.S. Food and Drug Administration seeks to accelerate development and regulatory review of potential new medicines to address a significant unmet medical need, the British pharmaceutical giant said.
The decision was based on positive results from a phase 3 trial, where Tagrisso reduced the risk of disease recurrence or death by around 80%, AstraZeneca said.
The designation covers the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection with curative intent, AstraZeneca said.
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