Tagrisso approved in Japan for 1st-line treatment of EGFR-mutated non-small cell lung cancer

AstraZeneca announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Tagrisso(osimertinib) for the 1st-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), following priority review. The approval is based on results from the global Phase III FLAURA trial which included Japanese patients and which were published in the New England Journal of Medicine.

Dave Fredrickson, Executive Vice President, Head of the 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 1st-line EGFR-inhibitor medicines. 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.”

The FLAURA trial compared Tagrisso to current 1st-line EGFR tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib in previously-untreated patients with locally-advanced or metastatic EGFR-mutated (EGFRm) NSCLC. In the trial, Tagrisso demonstrated superior progression-free survival (PFS) of 18.9 months compared with 10.2 months for the comparator arm (see table below), and this benefit was consistent across all subgroups including in patients with or without central nervous system (CNS) metastases, an important benefit for lung cancer patients.

FLAURA trial efficacy results according to investigator assessment

Efficacy parameter


EGFR-TKI comparator (gefitinib or erlotinib)


Number of events (62% maturity) 136 (49) 206 (74)
Median PFS (95%

confidence interval [CI])

18.9 months (15.2, 21.4) 10.2 months (9.6, 11.1)
Hazard ratio (HR [95% CI]); p-value 0.46 (0.37, 0.57); p < 0.0001
Objective response rate (ORR)
Response rate (95% CI) 80% (75, 85) 76% (70, 81)
Odds ratio (95% CI); p-value 1.3 (0.9, 1.9); p=0.2421
Duration of response (DoR)
Median DoR (95% CI) 17.2 months (13.8, 22.0) 8.5 months (7.3, 9.8)

Safety data for Tagrisso in the FLAURA trial were in line with those observed in prior clinical trials. Tagrisso was generally well tolerated, with Grade 3 or higher adverse events (AEs) occurring in 34% of patients taking Tagrisso and 45% in the comparator arm. The most common adverse reactions in patients treated with Tagrisso were rash/acne (54.5%), diarrhoea (49.5%), dry skin/eczema (33.3%) and nail disorder including paronychia (32.6%) (at the time of supplementary approval).

Tagrisso has now received approval in 40 countries for the 1st-line treatment of patients with metastatic EGFRm NSCLC, including the US, Japan and in Europe. Other global health authority reviews and submissions are ongoing.

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