FDA Approves Xalkori for Lung Cancer
Article date: August 29, 2011
By Stacy Simon
The drug is intended for patients who have the abnormal anaplastic lymphoma kinase (ALK) gene. It was approved with a companion diagnostic test to help determine whether patients have the ALK gene abnormality. About 1% to 7% of people with non-small cell lung cancer have the gene abnormality. The drug works by blocking certain proteins called kinases, including the protein produced by the ALK gene.
The safety and effectiveness of the drug were established in two studies of a total of 255 patients with late-stage ALK-positive non-small cell lung cancer. In one of the studies, 50% of patients taking Xalkori improved. In the other study, 61% improved.
Xalkori is a pill taken twice a day. The most common side effects included nausea, vomiting, diarrhea, constipation, edema (swelling) and vision disorders. The vision disorders included visual impairment, flashes of light, blurred vision, floaters, double vision, sensitivity to light and visual field defects.
Xalkori was approved under the FDA’s accelerated approval program for drugs that show promise against a serious disease. The company that makes the drug must submit additional clinical information after approval, to demonstrate its benefit. Although Xalkori has been shown to shrink tumors, it has not yet been shown to help patients live longer.
Xalkori should not be taken by patients who have had treatment-related pneumonitis or by pregnant women. The drug is marketed by Pfizer.
Reviewed by: Members of the ACS Medical Content Staff
ACS News Center stories are provided as a source of cancer-related news and are not intended to be used as press releases.
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