AstraZeneca receives full EU approval for lung cancer drug Tagrisso

AstraZeneca has announced that its lung cancer drug Tagrisso has been granted full marketing authorisation from the European Commission.

Following this upgrade from its previous conditional approval, the once-daily tablet therapy will now be made available for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer (NSCLC).

Developed as a potential new standard of care in second-line and subsequent therapy for this hard-to-treat form of lung cancer, Tagrisso has demonstrated its safety and efficacy in the phase III AURA3 trial.

AstraZeneca's drug demonstrated statistically significant improvements in progression-free survival compared to standard platinum-based doublet chemotherapy in 419 NSCLC patients whose disease had progressed on or after prior therapy.

Sean Bohen, executive vice-president for global medicines development and chief medical officer at AstraZeneca, said: "The full approval of Tagrisso in the EU is further evidence of our exciting progress in transforming the science of cancer care to deliver life-changing medicines to people most in need."

This comes after the drug was converted from accelerated to full approval in the US in March.

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