AstraZeneca’s Lung Cancer Drug Approved in Japan
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved AstraZeneca’s Tagrisso (osimertinib) 80-mg once-daily tablets for treating patients with epidermal growth factor receptor (EGFR) T790M mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC) that is resistant to EGFR tyrosine kinase inhibitor (TKI) therapy.
The full Japanese approval was granted seven months after the new drug application submission in August 2015. The Japanese approval for osimertinib was granted under the priority review mechanism of the MHLW, in recognition of the submitted data and the life-threatening nature of the disease. The Japanese approval follows US Food and Drug Administration accelerated approval in November 2015 and European Commission conditional marketing authorization in February 2016. Interactions with regulatory authorities in the rest of the world are ongoing.