The targeted drug Xalkori™ (crizotinib) has been approved by the US Food and Drug Administration for the treatment of advanced non-small lung cancer that has an abnormal version of the ALK gene.

Lung cancer is the leading cause of cancer death in the US and around the world, highlighting the importance of developing effective new approaches to treatment.

Up to 7% non-small cell lung cancers (NSCLC) have an abnormal version of the ALK gene. Lung cancers with this abnormality typically occur in non-smokers. The abnormal gene contributes to the growth and development of cancer cells.

Xalkori is an oral medication that blocks the protein produced by the abnormal ALK gene. The drug has been evaluated in two studies that enrolled a total of 255 patients with late-stage, ALK-positive NSCLC. ALK status is determined by testing a sample of tumor tissue.

In one of the studies, half the patients responded to treatment (had a partial or complete disappearance of detectable cancer). In the other study, 61% of patients responded to treatment. The most common side effects of Xalkori were vision disorders (such as visual impairment, flashes of light, and blurred vision), nausea, diarrhea, vomiting, swelling (edema), and constipation.

Xalkori was approved under the FDA’s accelerated approval program. This program allows patients early access to promising drugs, but the company that produces the drug will need to conduct additional studies to confirm a benefit.

A test to detect ALK abnormalities was approved at the same time as Xalkori.

Reference: US Food and Drug Administration News Release. FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer. August 26, 2011.

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