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FDA Approves Lung Cancer Drug Crizotinib, Costs Nearly $10K Monthly


Pfizer Inc. today received approval from the Food and Drug Administration (FDA) for its new lung cancer drug, crizotinib (Xalkori), which is for lung cancer patients who have an uncommon genetic mutation. The cost for this protection is steep: nearly $10K per month, although Pfizer says it will offer co-pay help for some privately insured patients.

Crizotinib can significantly shrink lung cancer tumors

Last year, the FDA agreed to fast-track its review of crizotinib, which is specifically for individuals with advanced lung cancer who have the anaplastic lymphoma kinase (ALK) translocation. The National Cancer Institute estimates that 2 to 7 percent of patients who have non-small cell lung cancer have a mutation of the ALK gene, which equals about 10,000 cases per year in the United States.

In trials reported in 2010, one found a 57 percent response rate in 82 patients with ALK-positive non-small cell lung cancer who were given crizotinib. Overall, 46 patients had a partial response, 1 had a complete response, and 27 (33%) had stable disease after a mean treatment duration of 6.4 months. Side effects included mild nausea, vomiting, diarrhea, and visual disturbances.

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Another study, also published in 2010, found that some patients positive for ALK who were treated with crizotinib have or developed other mutations that could confer resistance to the drug. Researchers are already investigating this phenomenon.

Because crizotinib may benefit only a small percentage of patients who have non-small cell lung cancer, they must first be identified. To accomplish this, Abbott Laboratories has developed a genetic test, called the Vysis ALK Break Apart FISH Probe Kit, which the FDA also approved. The cost of this test was not released.

Crizotinib is one of several drugs in a relatively new class that can target changes at the molecular level. This is a more precise form of treatment. In the case of crizotinib, it works by stopping the ALK gene from become active and nurturing the growth of lung cancer cells.

For the patients who have this specific genetic mutation, the cost of stopping it could be steep. Crizotinib reportedly carries a $9,600 per month price tag, plus the cost of the genetic testing from Abbott, and together this could be prohibitive for many. Pfizer stated that it is offering co-pay assistance for eligible, privately insured individuals, which will reduce the out-of-pocket to no more than $100 per month.

Kwak EL et al. Anaplastic lymphoma kinase inhibition in non-small cell lung cancer. New England Journal of Medicine 2010 Oct 28; 363(18): 1693-703
Wall Street Journal