Univ. of Chicago researchers license pharmacogenomics test for patients with colorectal canc...( aid Ratain. But finding the right dos...)

aid Ratain. "But finding the right dose is difficult because patients vary radically and unpredictably in how they respond to these drugs. Our goal is to determine how an individual's genetic makeup controls the ways he or she responds to these drugs -- how the medications are absorbed, distributed in the body, broken down and eliminated -- and to use that knowledge to determine the best possible dose for each patient."

"Our early studies with irinotecan demonstrated that the highly variable toxicity was related to variability in the drug's metabolism," he said. "We subsequently found that patients with two copies of one version of the UGT1A1 gene had few side effects at the standard dosage. Patients with only one copy of this version had more difficulty, and patients with two copies of the alternative version were at high risk for severe side effects.

"So relying on one standard dose meant that some of those patients received sub-therapeutic doses of irinotecan and others received more than they could manage. We envision that dosing based on the UGT1A1 test will have the dual advantage of reducing side effects and increasing benefit of this important drug."

Because of this study, the FDA, on June 7, 2005, required amendment of the package insert for Camptosar to include a warning that patients with a particular UGT1A1 genotype should receive a lower starting dose.

"With the growing interest in individualizing drug therapy, FDA's approval of this assay provides physicians and patients with important information on the proper dosage of drugs metabolized and cleared from the body by the UGT1A1 pathway," said Lawrence Lesko, Ph.D., Director of the FDA's Office of Clinical Pharmacology and Biopharmaceutics in the Center for Drug Evaluation and Research in a press release issued when the FDA approved UGT1A1 testing in August.

"Information on the UGT1A1 genotype can be an integral part of drug labels," he added, "and will gu
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Contact: John Easton
john.easton@uchospitals.edu
773-702-6241
University of Chicago Medical Center
21-Dec-2005

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