The European Medicines Agency (EMA) has recommended authorising Vizimpro (dacomitinib) monotherapy as first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.
Dacomitinib is a pan-human EGFR (EGFR/HER1, HER2 and HER4) inhibitor, with activity against mutated EGFR with deletions in exon 19 or L858R substitution in exon 21.
Previous research has shown that dacomitinib significantly improves progression-free survival (PFS) over gefitinib in first-line treatment of patients with EGFR-mutation-positive NSCLC.
In the international, multi-centre, phase 3 ARCHER 1050 study, at a median follow-up of 22.1 months, median PFS was 14.7 months (95% CI 11.1-16.6) in the dacomitinib group and 9.2 months (95% CI 9.1-11.0) in the gefitinib group (hazard ratio 0.59; 95% CI 0.47-0.74; P<.0001>
The most common grade 3-4 adverse events were dermatitis acneiform (14% of the dacomitinib group vs 0% of the gefitinib group), diarrhoea (8% vs 1%) and raised alanine aminotransferase levels (1% vs 8%).
Detailed recommendations for the use of dacomitinib will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.