Non-Small Cell Lung Cancer Drug Gets FDA Nod - in Oncology/Hematology, Lung Cancer from MedPage Today
"WASHINGTON -- The FDA has approved crizotinib (Xalkori), a novel targeted therapy for late-stage non-small cell lung cancer.
The Pfizer drug, an inhibitor of anaplastic lymphoma kinase, is a twice-daily pill intended for a select group of patients who express the abnormal anaplastic lymphoma kinase (ALK) gene, which causes cancer development and growth.
The FDA also approved a companion diagnostic called the Vysis ALK Break Apart FISH Probe Kid, made by Abbott Molecular, to help determine if a patient has the abnormal ALK gene.
"The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug," Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research said in a press release. "Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects."
Crizotinib's safety and effectiveness were established in two single-arm studies enrolling a total of 255 patients with late-stage ALK-positive non-small cell lung cancer. One of those studies, published in the New England Journal of Medicine last year, found that crizotinib shrank or eliminated 57% of ALK-positive non-small cell lung tumors.
The most common side effects reported in patients receiving crizotinib included vision disorders, nausea, diarrhea, vomiting, edema, and constipation."