Japanese MHLW approves AstraZeneca’s Tagrisso

The Japanese Ministry of Health, Labor and Welfare (MHLW) today approved AstraZeneca's Tagrisso (osimertinib, AZD9291).

The medication, which is an 80 mg, once per day tablet, is designed to treat patients with epidermal growth factor receptor (EGFR) T790M mutation-positive inoperable or recurring non-small cell lung cancer (NSCLC) that has shown a resistance to EGFR tyrosine kinase inhibitor (TKI) therapy.

Osimertinib has already been approved in the United States and Europe as a first-in-class treatment for lung cancer that targets the T790M mutation. With the MHLW approval, the medicine is now available to patients in Japan as well.

Data has shown that approximately 30 percent to 40 percent of Asian patients suffering from NSCLC already have the EGFR mutation when they are diagnosed. Roughly two out of three patients who have NSCLC whose disease progresses after treatments involving EGFR-TKI have developed the T790M mutation. In Japan, the treatment options for the mutation are currently limited.

Osimertinib targets the EGFR mutation that takes place during the development of cancer and the T790M mutation, which makes tumors resistant to current EGFR-TKI treatments. The Japanese approval of osimertinib came about because of two AURA Phase 2 trials that included Japanese patients.