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Crizotinib is now Xalkori

The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to the Pfizer, Inc. drug, crizotinib, which will now be marketed under the brand name, Xalkori. Xalkori is the first-ever drug approved for the treatment of advanced stage non-small cell lung cancer which has been determined to be ALK (anaplastic lymphoma kinase) positive. The companion diagnostic test, designed to detect rearrangements of the ALK gene, was approved concurrently. ALK mutations are found in approximately 4% to 5% of patients with non-small cell lung cancer. This accounts for somewhere between 6,000 and 11,000 new patients each year in the U.S.

Although at one time everyone diagnosed with lung cancer was treated the same, it was discovered some decades ago that a portion of patients could be cured with chemotherapy and radiation therapy. At this point, lung cancers were divided into the small cell and non-small cell groups. More recently, it was found that lung cancer is not a single disease, but rather a group of diseases with different molecular origins, and that some lung cancers carry mutations that respond to specific therapies. By testing for these mutations, and then targeting them with the appropriate therapies, it can be almost guaranteed that the patient will derive some benefit, even though the degree of benefit may vary from one patient to the next.

Research done by the Lung Cancer Mutation Consortium has shown that nearly 60% of lung adenocarcinomas have one of ten genomic abnormalities. Drugs for two of these abnormalities, namely the EGFR and ALK mutations, have now been approved. As more drugs for the remaining mutations are approved, patients will be treated more effectively, while avoiding treatments that have little or no efficacy.

NOTE: Like many targeted therapies, Xalkori comes with a high price tag. In light of this, Pfizer, the pharmaceutical manufacturer of the drug, is offering a number of cost assistance programs through their Pfizer First ResourceĀ® Program. If you need assistance, and to find out whether you qualify, call First Resource at 1-877-744-5675.