AstraZeneca gets further approval for Tagrisso in Japan

AstraZeneca received approval from the Japanese regulator following a priority review of Tagrisso (osimertinib) as a first-line treatment of patients with positive non-small cell lung cancer (NSCLC), further expanding its currently authorised use in this country.

The Japanese Ministry of Health, Labour and Welfare has approved Tagrisso in a new indication for the 1st-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive NSCLC.

The approval is based on results from the global phase 3 FLAURA trial, which included Japanese patients, and which were published in the New England Journal of Medicine.

The results of the FLAURA trial compared Tagrisso to currently approved as a first-line treatment EGFR tyrosine kinase inhibitors, Roche’s Tarceva (erlotinib) or Astra’s own Iressa (gefitinib) in previously-untreated patients with locally-advanced or metastatic EGFR-mutated NSCLC.

In the trial, Tagrisso demonstrated “superior” progression-free survival of 18.9 months, compared with 10.2 months for the comparator arm.

This benefit was consistent across all subgroups including in patients with or without central nervous system metastases, which is an “important benefit for lung cancer patients” according to Astra.

[caption id="attachment_37426" align="alignleft" width="95"] Dave Fredrickson[/caption]

Dave Fredrickson, head of AstraZeneca’s oncology business unit said: “The 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.”

Safety data for Tagrisso was in line with that observed in prior clinical trials with the drug being generally well tolerated, with grade 3 or higher adverse events occurring in 34% of patients taking Astra’s new treatment and 45% in the comparator arm.

The most common adverse reactions in patients treated with Tagrisso were rash or acne, diarrhoea, dry skin or eczema, and nail disorder including paronychia.

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.

The drug has now received approval in 40 countries for the first-line treatment of patients with metastatic EGFR NSCLC, including the US, Japan and in Europe with other health authority reviews and submissions ongoing in other countries.