AstraZeneca: new approval for Tagrisso in US

(CercleFinance.com) - AstraZeneca announced on Thursday that the US FDA has approved the use of its Tagrisso for the treatment of patients with stage 3 non-operable non-small cell lung cancer (NSCLC).


The pharmaceutical company points out that the FDA's NOC refers to the form of the disease expressing the epidermal growth factor receptor gene 'EGFRm'.

It is intended for patients with a deletion in exon 19 or a substitution mutation in exon 21 whose disease has not progressed following radiochemotherapy.

AstraZeneca says that the approval, which follows the granting of a priority review procedure, was granted on the basis of the results of a Phase III clinical trial.

In this trial, Tagrisso reduced the risk of disease progression or death by 84% compared to placebo, with a median progression-free survival of 39.1 months in patients treated with Tagrisso, compared to 5.6 months in the placebo group.


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