Dacomitinib to treat patients with NSCLC in EU

June 11, 2019 0 By FM

Pfizer Inc. announced that the EC has approved dacomitinib (Vizimpro), a tyrosine kinase inhibitor (TKI), as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

The EC approval of dacomitinib was supported by data from ARCHER 1050, a randomized, multicentre, multinational, open-label, phase 3 study conducted in patients with unresectable, metastatic or recurrent NSCLC, harbouring EGFR exon 19 deletion or exon 21 L858R substitution mutations.

Dacomitinib is also approved in the US 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. Additionally, it is approved in Japan for EGFR gene mutation-positive, inoperable or recurrent NSCLC, and in Canada for the first-line treatment of adult patients with unresectable locally advanced or metastatic NSCLC with confirmed
EGFR exon 19 deletion or exon 21 L858R substitution mutations. The applications in the US and Japan were reviewed and approved under the Priority Review programme.