AstraZeneca’s Tagrisso accepted for EU review in new lung cancer indication

AstraZeneca has announced that its cancer drug Tagrisso has been accepted for European regulatory review in a new lung cancer indication.

The European Medicines Agency has accepted a variation to the marketing authorisation application for Tagrisso and will assess the drug as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EFGR) mutations.

Tagrisso is a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI) that has demonstrated clinical activity against central nervous system metastases, with this latest submission based on positive data from the phase III FLAURA study.

In this trial, Tagrisso was shown to significantly improve progression-free survival rates compared to current first-line EGFR-TKI therapies in previously untreated patients with locally advanced or metastatic EGFR-positive NSCLC.

The drug has already been approved in more than 60 countries and regions – including the US, EU, Japan and China – for patients with EGFR T790M mutation-positive advanced NSCLC, and is also being investigated in the adjuvant setting and in combination with other treatments.

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