AstraZeneca's Tagrisso recommended for EU approval

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.

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