EMA OK’s AZ’s Tagrisso variation to the marketing authorisation applicatoin

The European Medicines Agency has accepted a variation to the Marketing Authorisation Application (MAAv) for Tagrisso (osimertinib) from Astrazeneca.

Acceptance is based on positive Phase III FLAURA trial results.

That is a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, for the 1st-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations).