Regulatory Focus™ > News Articles > 2019 > 3 > EMA Begins Review of Screening Patients Before Fluorouracil

EMA Begins Review of Screening Patients Before Fluorouracil

Posted 15 March 2019 | By Zachary Brennan 

EMA Begins Review of Screening Patients Before Fluorouracil

The European Medicines Agency (EMA) on Friday initiated a review of existing screening methods and their value in identifying patients at increased risk of severe side effects when taking medicines containing fluorouracil (also known as 5-fluorouracil or 5-FU) and the related medicines capecitabine, tegafur and flucytosine, which are converted to fluorouracil in the body.

Fluorouracil, given by injection, capecitabine and tegafur are cancer medicines, while topical fluorouracil is used for various skin conditions and flucytosine is a medicine used in severe fungal infections, according to EMA. For some patients that lack a working enzyme called dihydropyrimidine dehydrogenase (DPD), their bodies cannot break down fluorouracil, resulting in its build-up in the blood. And such build-ups can lead to severe and life-threatening side effects.

A trial in France is looking into the deaths of four patients following the administration of 5-FU, after they were not tested for DPD deficiency.

According to a Medscape article: “European experts have openly questioned whether DPD testing should be incorporated into oncology practice in order to safeguard patients.”

EMA explained: “Genetic testing for DPD deficiency is recommended for most medicines used in the treatment of cancer, but systematic screening for DPD deficiency before starting treatment is not mandatory. In addition, new data on genetic testing and other DPD screening methods were recently published which may impact current recommendations.”

A study published last July from French researchers looked at “a simple, rapid and cheap functional testing that helps categorizing patients on their DPD status and detecting poor metabolizer (PM) patients.” The study said it “shows that 5-FU-related toxicities can be avoided at low cost by the upfront detection of DPD deficient patients with simple adaptive dosing strategies.”

EMA, meanwhile, said it will now assess the available data in relation to existing screening methods to detect DPD deficiency and recommend whether changes are necessary for how these medicines are used.

The review is being carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which will make a set of recommendations to be forwarded to EMA’s Committee for Medicinal Products for Human Use (CHMP), which will adopt an opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU member states.

EMA

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe