AstraZeneca's Tagrisso approved in Japan

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Tagrisso (osimertinib, AZD9291) 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 (TKI) therapy, the drug’s maker, AstraZeneca (LSE: AZN), announced today.

Sean Bohen, executive vice president, global medicines development and chief medical officer at the Anglo-Swedish drugmaker, said: “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.”

Blockbuster sales forecast

Tagrisso is one of several cancer investigational drugs that AstraZeneca hopes will rebuild its sales following patent losses on older drugs. The company has previously forecast the drug could eventually sell as much as $3 billion a year. However, industry analysts are more cautious about sales in the next few years, with consensus expectations pointing to revenue of $1.1 billion in 2020, according to Thomson Reuters Cortellis.