Dacomitinib: First Global Approval.

Dacomitinib (Vizimpro®) is an orally administered, small-molecule irreversible inhibitor of HER1 (EGFR), HER2 and HER4 that was developed by Pfizer Inc. for the treatment of solid tumours. In September 2018, dacomitinib received its first global approval, in the USA, for use in the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Registration applications for the use of dacomitinib as first-line treatment for patients with EGFR-mutation-positive metastatic NSCLC have also been submitted in the EU and Japan. This article summarizes the milestones in the development of dacomitinib leading to this first approval for the first-line treatment of patients with EGFR-mutated metastatic NSCLC.