Health Canada approves AstraZeneca's Tagrisso

12 July 2016

The Canadian subsidiary of Anglo-Swedish pharma major AstraZeneca (LSE: AZN) has received approval for medicines regulator Health Canada for Tagrisso (osimertinib) once-daily tablets for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

The approval is the result of one of the fastest development programs from start of clinical trials to regulatory clearance, according to AstraZeneca. Tagrisso's path to market has been unusually fast, taking just over two and a half years from the start of clinical trials to approval in the USA, the world's biggest drugs market. Tagrisso gained accelerated approval from the US Food and Drug Administration last November, in February this year it was granted conditional marketing authorization by the European Commission and in March it was cleared in Japan.

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