Dacomitinib: First Global Approval
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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.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflicts of interest
During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Matt Shirley is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
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