The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Tagrisso (osimertinib) for the first-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), following priority review, Anglo-Swedish pharma major AstraZeneca (LSE: AZN) announced today.
The approval is based on results from the global Phase III FLAURA trial, which included Japanese patients and were published in the New England Journal of Medicine.
Tapping into this market sector in Japan is also important for AstraZeneca, with the company predicting that Tagrisso could clock up annual sales of up to $4 billion. The drug generated sales of $955 million in 2017.
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