FDA Approves Vizimpro for Metastatic NSCLC

The U.S. Food and Drug Administration (FDA) has approved Vizimpro (dacomitinib tablets) a kinase inhibitor as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 L858R substitution mutations. “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,” Andy Schmeltz, global president at Pfizer Oncology, said in the release.3

Clinical trial results

Approval of Vizimpro was based on the data from a randomized, multicenter, open-label, active-controlled trial (Phase III ARCHER 1050). This clinical trial compared the safety and efficacy of Vizimpro with that of Irressa (gefitinib) in 452 patients with unresectable, metastatic NSCLC. Those participating patients had no prior therapy for metastatic disease or recurrent disease with a 12 month disease-free minimum. Although there were no improvements in overall response rate or survival, results offer positive improvements in progression-free survival. Progression-free survival refers to the length of time during and following treatment that a patient lives with the disease but it does not get worse. The median progression-free survival was 14.7 months for patients on Vizimpro and 9.2 months for those on Iressa.

The most common reactions included diarrhea (87%), rash (69%), paronychia (64%), stomatitis (45%), decreased appetite (31%), dry skin (30%), decreased weight (26%), alopecia (23%), cough (21%) and pruritus (21%). Serious adverse reactions occurred in 27% of patients.

More options for EGFR

This approval marks another progressive step forward in lung cancer research development, especially for those with the EGFR-mutation. Mace Rothenberg, chief development officer of oncology, Pfizer Global Product Development, notes “Pfizer now has two medicines that can tackle three different forms of mutation-driven lung cancer: Xalkori for patients with ALK-positive or ROS1-positive non-small-cell lung cancer and Vizimpro for patients with EGFR-mutated non-small cell lung cancer.”3

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