BRIEF—AstraZeneca seeks to extend label for Tagrisso in Japan

UK-based AstraZeneca has submitted a supplemental new drug application to Japan’s medicines regulator, in a bid to extend the marketable use of its tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib).

If successful, the drug will be marketable in Japan as a first-line treatment for certain patients with inoperable or recurrent EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).

The application is based on data from the Phase III FLAURA trial,which showed improved progression-free survival compared to current first-line TKIs Tarceva (erlotinib), jointly developed by Roche and Astellas, and the firm’s own Iressa (gefitinib).