FDA approved Xalkori with companion diagnostic test for a type of late stage lung cancer.

The U.S. Food and Drug Administration approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who expressed the abnormal anaplastic lymphoma kinas (ALK) gene.

Xalkori is being approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, a genetic test called the Vysis ALK Break Apart FISH Probe Kit.

The ALK gene abnormality causes cancer development and growth. About 1 to 7 percent of those with NSCLC have the ALK gene abnormality.

Patients with this form of lung cancer are typically non-smokers. Xalkori works by blocking certain proteins called kinases, including the protein produced by the abnormal ALK gene. Xalkori is a pill taken twice a day as a single agent treatment.

"The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug" said Richard Pazdur, M.D., director of the Office of Oncology Drug products in the FDA's Center for Drug Evaluation and Research. "Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects."

Xalkori safety and effectiveness were founded in two multi-centers, single-arm studies, which involved obtaining sample of patients with late stage ALK positive NSCLC. The response rate was 50 to 61 percent with median response duration of 42-48 weeks.

Xalkori was approved under the FDA's accelerated approval program, which allows the FDA to approve the drug to treat a serious disease based on clinical data showing that the dug has an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients.

Xalkori is marketed by New York City based Pfizer. The Vysis ALK Break Apart FISH Probe Kit is marketed by Abbott Molecular INC. of Des Plaines, Ill.