Navigation Links
UNC study questions FDA genetic-screening guidelines for cancer drug
Date:8/28/2007

CHAPEL HILL Not everyone needs a genetic test before taking the cancer drug irinotecan, and the U.S. Food and Drug Administration should modify its prescription guidelines to say so, according to researchers at the University of North Carolina at Chapel Hill.

Irinotecan, also known by its brand name Camptosar, is used mainly as a second-line treatment for colorectal cancer. The FDA recommends screening patients for a gene that could make them more susceptible to the harmful side effects of the drug, the most worrisome of which is neutropenia, an abnormally low number of white blood cells.

In a paper published in the Aug. 28, 2007 Journal of the National Cancer Institute, UNC researchers analyzed data from nine previous studies of irinotecan. They found that patients who received a medium or high dose of the drug had greater risk of neutropenia if they had two copies of a variation of the gene UGT1A1, known as UGT1A1*28. At lower doses, however, the risk was the same regardless of what UGT1A1 gene the patients had.

Many institutions saw the FDAs recommendation as a mandate to test all patients before treating them with irinotecan even though many clinicians didnt think it was always necessary given that low doses of the drug werent causing problems, said Howard McLeod, Pharm.D., senior author of the study and director of the UNC Institute for Pharmacogenomics and Individualized Therapy.

Our review showed that at low doses the drug is well tolerated and can be taken by most people, McLeod said. As the dosage increases, genetics become a larger factor in determining what side effects patients experience, and then testing becomes essential.

Having a genetic test available for a medicine is valuable, but so is knowing when to use that test, said Dr. Richard Goldberg, a co-author of the study and physician in chief of the North Carolina Cancer Hospital.

There are so many treatment options for cancer patients that the more information we have about matching the right therapy to the patient, the better off we all are, Goldberg said. Studies like this one give oncologists the tools needed to take better care of patients while avoiding tests and expenses that arent needed.

The authors recommended that the FDA amend the product information for irinotecan to describe the association between irinotecan dose and risk of hematologic toxicity among patients with two UGT1A1*28 genes.


'/>"/>
Contact: Clinton Colmenares
clinton_colmenares@unc.edu
919-843-1991
University of North Carolina at Chapel Hill
Source:Eurekalert

Related biology news :

1. Bioartificial kidney under study at MCG
2. Novel Asthma Study Shows Multiple Genetic Input Required; Single-gene Solution Shot Down
3. W.M. Keck Foundation funds study of friendly microbes
4. Yellowstone microbes fueled by hydrogen, according to U. of Colorado study
5. Emory Study Tests Bone Marrow Stem Cells to Improve Circulation in Legs
6. UCLA Study Shows One-Third of Drug Ads in Medical Journals Do Not Contain References Supporting Medical Claims
7. Study Demonstrates Gene Expression Microarrays are Comparable and Reproducible
8. Study Links Ebola Outbreaks To Animal Carcasses
9. Genome-wide mouse study yields link to human leukemia
10. Breakthrough Microarray-based Technology for the Study of Cancer
11. NYU Study Reveals How Brains Immune System Fights Viral Encephalitis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/29/2016)... CANNES, France , November 29, 2016 Nearly ... Continue Reading ... ... System is part of an efficient Identity Management. (PRNewsFoto/DERMALOG Identification Systems) ... DERMALOG is Germany's largest Multi-Biometric ...
(Date:11/21/2016)... Nov. 21, 2016   Neurotechnology , a ... technologies, today announced that the MegaMatcher On Card ... submitted for the NIST Minutiae Interoperability Exchange ... the mandatory steps of the evaluation protocol. ... continuing test of fingerprint templates used to establish ...
(Date:11/15/2016)... 2016  Synthetic Biologics, Inc. (NYSE MKT: SYN), ... the gut microbiome, today announced the pricing of ... its common stock and warrants to purchase 50,000,000 ... to the public of $1.00 per share and ... the offering, excluding the proceeds, if any from ...
Breaking Biology News(10 mins):
(Date:12/2/2016)... , ... December 01, 2016 , ... ... long-term client Nanowear on their recent FDA Class II 510(k) clearance for their ... significant hurdle in commercializing remote cardiac monitoring devices that rely on cloth-based nanosensors. ...
(Date:12/2/2016)... bioLytical Laboratories, a world leader in rapid infectious disease tests, introduced the Company,s newest ... members. (Photo: http://photos.prnewswire.com/prnh/20161201/444905 ) Continue Reading ... ... , , bioLytical was invited ... introduce the INSTI HIV Self Test to 350 pharmacy representatives in Nairobi ...
(Date:11/30/2016)... Nov. 30, 2016 Biotest Pharmaceuticals Corporation (BPC), ... to announce the addition of its newest plasma collection ... Nebraska . The 15,200 square foot state-of-the-art facility ... 2016 and brings the total number of BPC,s plasma ... Carlisle , BPC,s Chief Executive Officer said "We are ...
(Date:11/30/2016)... November 2016   Merck , ein ... Unterzeichnung einer Reihe von Vereinbarungen mit Evotec ... AG Screeningleistungen für Mercks Palette genetischer Reagenzien ... auf diese Bibliotheken in Kombination mit Evotecs ... Weg zur Ermittlung und Erforschung neuer Arzneimitteltargets.    ...
Breaking Biology Technology: