Dacomitinib to treat NSCLC in Europe

April 9, 2019 0 By FM

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending dacomitinib 45 mg (Vizimpro) for the first-line treatment advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations, according to Pfizer.

Dacomitinib is an oral, once-daily, irreversible pan-human epidermal growth factor receptor kinase inhibitor.

Dacomitinib was approved by the US FDA in 2018 for 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. It was also recently approved in Japan for EGFR gene mutation-positive, inoperable or recurrent NSCLC

The Marketing Authorization Application (MAA) for dacomitinib was based on results from ARCHER 1050, a randomized, multicentre, multinational, open-label, phase 3 study conducted in patients with locally advanced unresectable, or metastatic NSCLC harbouring EGFR exon 19 deletion or exon 21 L858R substitution mutations, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy.