AstraZeneca’s Tagrisso gets green light to be first-line treatment in Japan

The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved AstraZeneca’s Tagrisso (osimertinib) as a first-line treatment of patients with inoperable or recurrent epidermal growth factor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

“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,” stated Dave Fredrickson, executive vice president, head of the Oncology Business Unit, AstraZeneca. “[This] 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.”

The approval has been based on the results of the Phase III FLAURA trial, comparing Tagrisso to the current first-line EGFR tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib in treatment-naïve patients with locally-advanced or metastatic EGFR-mutated NSCLC.

Results of the trial demonstrated that Tagrisso had superior progression-free survival (PFS) of 18.9 months compared with 10.2 months for the comparator arm. This was true across all subgroups in the trial.

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases. Once-daily oral tablets of 40 mg and 80 mg have now received approval in 40 countries, including the US, Japan and in Europe, for first-line EGFRm advanced NSCLC, and more than 75 countries, including the US, Japan, China and in Europe, for second-line use in patients with EGFR T790M mutation-positive advanced NSCLC.

The product is also being developed in the adjuvant setting (ADAURA), in the locally-advanced unresectable setting (LAURA), and in combination with other treatments.