2 February 2019 - Pfizer today announced that the CHMP of the EMA has adopted a positive opinion recommending Vizimpro (dacomitinib) 45 mg, as monotherapy, be granted marketing authorisation in the European Union for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor activating mutations. 

Vizimpro was approved by the U.S. FDA in 2018 for the first-line treatment of patients with metastatic non-small cell lung cancer (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 authorisation application for Vizimpro was based on results from ARCHER 1050, a randomised, multicenter, 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 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.

Read Pfizer press release