8 April 2019 - - 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 (NSCLC) with epidermal growth factor receptor -activating mutations, US-based biopharmaceutical company Pfizer Inc. (NYSE: PFE) said.

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 harboring EGFR exon 19 deletion or exon 21 L858R substitution mutations.

A total of 452 patients were randomized 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.

A statistically significant improvement in PFS as determined by the IRC was demonstrated for patients randomized to Vizimpro compared with gefitinib (HR = 0.59 [95% CI: 0.47, 0.74], p