Japan approves AstraZeneca's Tagrisso in EGFRm non-small cell lung cancer

AstraZeneca has revealed that its EGFR tyrosine kinase inhibitor Tagrisso (osimertinib) has been approved in Japan by the nation’s Ministry of Health, Labour and Welfare (MHLW) as a first-line therapy in patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

The decision, made under priority review, was based on evidence generated from the Phase 3 FLAURA trial, which pitted Tagrisso against the first-line EGFR TKIs erlotinib or gefitinib in treatment-naïve patients with locally-advacned or metastatic EGFR-mutated NSCLC.

It was found that AZ’s drug recorded superior progression-free survival (PFS) of 18.9 months compared to just 10.2 months for its rivals. The benefits for Tagrisso remained consistent across all subtypes, including in patients with or without central nervous system metastases.

"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 1st-line EGFR-inhibitor medicines," commented Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca. "Today’s approval moves the use of Tagrisso to the 1st-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."

This latest approval means that AZ’s drug is now approved to treat metastatic EGFRm NSCLC in 40 countries around the world, with more submissions to come, according to the company.

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