Non-Small Cell Lung Cancer Drug Gets FDA Nod
By Emily P. Walker, Washington Correspondent, MedPage Today
August 26, 2011
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
The most common side effects reported in patients receiving crizotinib included vision
disorders, nausea, diarrhea, vomiting, edema, and constipation.
Crizotinib was approved under the FDA's priority review program, which provides for
an expedited six-month review of drugs that may offer major advances in treatment or
that provide a treatment when no adequate therapy exists.
Since publication of trial results last October, crizotinib has generated much
excitement among oncologists who said genetically-targeted treatments like crizotinib
have the potential to change how cancer is treated.Although no more than 7% of non-small cell lung cancers are driven by the ALK
genes targeted by crizotinib, the drug would still benefit as many as 10,000 patients
with non-small cell lung cancer in the U.S. alone, Gregory Kalemkerian, MD,
co-director of thoracic oncology at the University of Michigan in Ann Arbor, told
Medpage Today last year.
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