Dacomitinib to treat metastatic NSCLCDecember 13, 2018
Pfizer Inc said the USFDA has approved dacomitinib (Vizimpro) to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body.
Dacomitinib is a kinase inhibitor indicated for first-line treatment of patients with metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
The safety and efficacy of dacomitinib wasdemonstrated in Archer 1050, a randomized, multicenter, multinational, open-label study. A total of 452 patients were randomized 1:1 to dacomitinib or gefitinib.
A statistically significant improvement in PFS, as determined by the IRC, was demonstrated for patients randomized to dacomitinib compared with gefitinib (HR = 0.59 [95% CI: 0.47, 0.74], p months (95% CI: 11.1, 16.6) compared with 9.2 months (95% CI: 9.1, 11.0) in the gefitinib arm.