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EMA Starts Review on DPD Testing Before Chemotherapy

2019/3/22 16:05:34 source:Medscape Author: Print

The European Medicines Agency (EMA) has started a review into the screening of patients before they begin treatment with certain drugs.

 
Most of the drugs in question are chemotherapies, and they include 5-fluorouracil (5-FU) and the related drugs capecitabine (Xeloda, Genentech) and tegafur, which are converted to fluorouracil in the body. These chemotherapies are very widely used in the treatment of a variety of cancer types, including colorectal, breast, and head and neck cancers.
 
This class of drugs also includes flucytosine (Ancobon, Valeant Pharmaceuticals), which is used for severe fungal infections.
 
The review will examine existing screening methods and their value in identifying patients who are at increased risk of severe side effects with these therapies, the agency notes. 
 
The screening methods aim to identify individuals who are deficient in the enzyme dihydropyrimidine dehydrogenase (DPD), which is needed to break down fluorouracil.
 
Without this enzyme, levels of the drug can build up in the body to toxic, even life-threatening levels, with side effects that include neutropenia, neurotoxicity, severe diarrhea, and stomatitis, the agency notes.
 
"Patients with a complete deficiency of DPD should therefore not be given fluorouracil, or medicines that can form it in the body," the agency notes. The product information for most of these medicines states that they should not be used in patients with complete DPD deficiency, it adds.
 
Genetic testing for DPD deficiency is recommended for most medicines used in the treatment of cancer, but systematic screening for DPD deficiency beforestarting treatment is not mandatory. In addition, new data on genetic testing and other DPD screening methods have recently been published, and these may impact current recommendations, the agency notes.
 

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