The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Astra Zeneca’s Tagrisso (osimertinib) for a type of inoperable lung cancer.
Dave Fredrickson, executive vice president, head of the Oncology Business Unit, said: “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) nonsmall cell lung cancer.
In the trial, Tagrisso showed progression-free survival of 18.9 months compared with 10.2 months with another therapy.
Safety data for Tagrisso in the FLAURA trial were in line with those observed in prior clinical trials.
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 continue.
Tagrisso is administered with 40mg and 80mg once-daily oral tablets.
AstraZeneca has 1,500 employees and its U.S. headquarters in northern Delaware.
