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

“Improving outcomes for patients is the central focus of why we develop and deliver new medicines. Vizimpro is yet another example of Pfizer’s commitment to providing more options in lung cancer where there is great unmet need,” said Andy Schmeltz, global president, Pfizer Oncology. “With today’s approval, Pfizer has medicines that target three unique lung cancer biomarkers, marking real progress for patients which has been achieved through a diverse and persistent drug development approach.”