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AstraZeneca’s Tagrisso gets EU lung cancer sign-off

AZ sign

The European Commission (EC) has granted conditional marketing authorisation to AstraZeneca’s Tagrisso to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) that tests positive a specific mutation.

Tagrisso (AZD9291, osimertinib) is the first medicine indicated for patients with epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC. Mutations in the EGFR receptor can lead to uncontrolled cell growth and tumour formation.

AstraZeneca earns ‘speedy’ FDA approval for lung cancer drug

AstraZeneca chief executive Pascal Soriot

The FDA has approved AstraZeneca’s new lung cancer drug Tagrisso, in a record two and half years from development, under the regulator’s accelerated approval pathway.

Tagrisso (AZD9291) is a once-daily tablet patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose cancer has progressed while they have been on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) therapy.

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