UK-based pharmaceutical company AstraZeneca has announced that its Tagrisso (osimertinib) has been approved by the Japanese Ministry of Health, Labour and Welfare for the first line treatment of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

Both doses, once-daily 40mg and 80mg oral tablets, have been approved by the Japanese authorities.

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The decision was based on results from AstraZeneca’s phase III Flaura trial in which Tagrisso showed progression free survival of 18.9 months, compared to 10.2 months for the EGFR tyrosine kinase inhibitors (TKIs) comparator of erlotinib or gefitinib.

Tagrisso also showed benefits across all sub-groups, including patients with or without central nervous system metastases.

The drug’s safety data was in line with those observed in previous clinical trials: 34% of patients taking the drug had grade three or higher adverse events, compared to 45% for the comparator group. The most common adverse events associated with Tagrisso were rash or acne, diarrhoea, dry skin and nail disorders.

Tagrisso is a third generation, irreversible EGFR-TKI designed to inhibit EGFR-sensitising and EGFR T790M resistant mutations. AstraZeneca executive vice-president and head of the oncology business unity Dave Fredrickson 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.”

Tagrisso is approved for first line treatment of EGFR-mutated NSCLC in 40 countries worldwide, including the US, China and EU countries. The European Medicines Agency approved the drug for line use in November 2017 and the US Food and Drug Administration followed suit in April 2018.

The drug is currently being investigated through trials in the adjuvant, or post-therapy, setting.