Approval in Japan for AstraZeneca lung cancer treatment

The Japanese Ministry of Health, Labour and Welfare delivered good news to AstraZeneca on Tuesday morning, approving the FTSE 100 drug company's Tagrisso (osimertinib) tablets for the treatment of 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 therapy.

"We continue to move at an unprecedented pace with osimertinib, with the full approval in Japan following closely the recent US and EU approvals. As first-in-class lung cancer treatment directed at the T790M mutation, we are delighted that this targeted medicine is now available to patients in Japan to address the existing unmet medical need," said Sean Bohen, executive vice president, global medicines development and AstraZeneca's chief medical officer.

AstraZeneca said 30-40% of Asian patients with NSCLC have the EGFR mutation at diagnosis, with two out of three patients whose disease progresses after treatment with tyrosine kinase inhibitor therapy develop the T790M mutation, with treatment options currently limited.

"A significant proportion of Japanese patients with lung cancer have the EGFR mutation and about 60% of them are likely to develop the T790M resistance mutation following initial TKI treatment. Osimertinib enables us to respond to this disease progression in a precise and logical way as clearly demonstrated in clinical trials, with potential to make a meaningful difference to the lives of Japanese patients," said Dr Tetsuya Mitsudomi of the division of thoracic surgery at Kinki University Faculty of Medicine.

The full Japanese approval was granted seven months after the new drug application submission in August 2015, and followed FDA approval in the US in November and European Commission conditional marketing authorisation in February.

AstraZeneca confirmed it had agreed a Risk Management Plan with the Japanese Health Authority.