Posted by Michael Wonder on 28 Sep 2018
U.S. FDA approves Vizimpro (dacomitinib) for the first-line treatment of patients with EGFR mutated metastatic non-small cell lung cancer
27 September 2018 - Approval supported by data from Phase 3 head-to-head study versus gefitinib.
Pfizer today announced that the U.S. FDA has approved Vizimpro (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (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 Vizimpro was demonstrated in ARCHER 1050, a randomised, multi-center, multinational, open-label study. Patients were required to have unresectable, metastatic NSCLC with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; EGFR exon 19 deletion or exon 21 L858R substitution mutations.
