AstraZeneca's Tagrisso gains approval in Japan for the first-line treatment of patients with NSCLC

AstraZeneca announced Tuesday that the Japanese Ministry of Health, Labour and Welfare approved Tagrisso (osimertinib) for the first-line treatment of patients with inoperable or recurrent EGFR mutation-positive non-small-cell lung cancer (NSCLC). The clearance of the drug, which followed priority review, is based on results from the Phase III FLAURA trial.

The study enrolled 556 previously-untreated subjects, including Japanese patients, with locally-advanced or metastatic EGFR mutation-positive NSCLC who were administered either Tagrisso or standard-of-care EGFR tyrosine kinase inhibitors. In the trial, Tagrisso demonstrated superior progression-free survival of 18.9 months compared with 10.2 months for the comparator arm, with this benefit consistent across all subgroups including patients with or without central nervous system metastases.

Dave Fredrickson, head of AstraZeneca's oncology business unit, said "Tagrisso is already approved in Japan for the treatment of patients with EGFR T790M mutation-positive inoperable or recurrent NSCLC that is resistant to existing first-line EGFR-inhibitor medicines." Fredrickson added that the latest "approval moves the use of Tagrisso to the first-line setting, replacing older medicines which, given the high prevalence of the EGFR mutation in Japan, offers an important new treatment option for these patients."

AstraZeneca noted that Tagrisso is now approved in 40 countries for the first-line treatment of patients with metastatic EGFR mutation-positive NSCLC, including Europe and the US. The drug is also being developed in the adjuvant setting, in the locally-advanced unresectable setting and in combination with other treatments. Last month, the country reported that second-quarter sales of Tagrisso jumped 82 percent year-over-year to $422 million.

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