AstraZeneca's Tagrisso recommended for EU approval
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Drugmaker AstraZeneca said on Monday that its Tagrisso asset had received a recommendation for EU approval on the back of LAURA Phase III trial results, which revealed it had extended median progression-free survival to more than three years.
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AstraZeneca said Tagrisso had been recommended for approval in the EU by the Committee for Medicinal Products for Human Use for patients with unresectable epidermal growth factor receptor-mutated lung cancer.
The FTSE 100-listed group stated trial results had shown Tagrisso reduced the risk of disease progression or death by 84% compared to placebo. Median progression-free survival was 39.1 months in patients treated with Tagrisso versus 5.6 months for the placebo.
AstraZeneca's Susan Galbraith said: "Today's news reinforces Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer, meeting the critical unmet need for an effective targeted treatment option in the unresectable setting.
"Tagrisso has now demonstrated its benefit across all stages of EGFR-mutated lung cancer, representing a pivotal step in transforming care for patients who are urgently in need of innovative therapies that can help extend their lives."
As of 0910 GMT, AstraZeneca shares were down 1.14% at 9,864.0p.
Reporting by Iain Gilbert at Sharecast.com