FDA approves Pfizer's Vizimpro as first-line rare NSCLC treatment

Though a long time coming given earlier failure in two clinical trials in 2014, the US Food and Drug Administration has now 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, from US pharma giant Pfizer (NYSE: PFE),

Vizimpro was reviewed and approved under the FDA’s Priority Review program. It will compete in a market sector that has significant existing completion, namely in the form of AstraZeneca’s (LSE: AZN) Iressa (gefitinib), Roche’s (ROG: SIX) Tarceva (erlotinib) and Boehringer Ingelheim’s Giotrif (afatinib) in treating NSCLC patients with EGFR mutations, in the first-line setting