AstraZeneca PLC on Thursday said that its cancer drug Tagrisso has been approved in the US for certain type of lung cancer.
The Cambridge-based pharmaceutical company said the approval was for adults with unresectable, stage III epidermal growth factor receptor-mutated non-small cell lung cancer whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy.
AstraZeneca said the approval by the Food & Drug Administration followed a priority review by the FDA based on results from a phase 3 trial.
The company said Tagrisso reduced the risk of disease progression or death by 84% compared to placebo, as assessed by a blinded independent central review. Median progression-free survival was 39.1 months in patients treated with Tagrisso compared to 5.6 months for placebo.
AstraZeneca highlighted that overall survival results remain ‘immature at this current analysis’.
AstraZeneca shares were 0.2% higher at 11,592.00 pence each on Thursday morning in London.
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