Posted by Michael Wonder on 04 Apr 2019
Vizimpro (dacomitinib) receives marketing authorisation in European Union for the first-line treatment of adult patients with EGFR mutated non-small cell lung cancer
3 April 2019 - Pfizer today announced that the European Commission has approved Vizimpro (dacomitinib), a tyrosine kinase inhibitor, as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor-activating mutations.
The European Commission’s approval of Vizimpro was supported by data from ARCHER 1050, a randomized, multicenter, multinational, open-label, Phase 3 study conducted in patients with unresectable, metastatic or recurrent NSCLC harbouring EGFR exon 19 deletion or exon 21 L858R substitution mutations. A total of 452 patients were randomised 1:1 to Vizimpro 45 mg (n=227) or gefitinib 250 mg (n=225). The primary endpoint was progression-free survival as determined by blinded Independent Radiologic Central review. Key secondary endpoints included PFS assessed by the investigator, objective response rate, duration of response and overall survival.
