January, 2025
January 2025
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Karen Merritt: Hoping for labelling updates to recommend pre-treatment DPD deficiency testing
Jan 30, 2025, 08:53

Karen Merritt: Hoping for labelling updates to recommend pre-treatment DPD deficiency testing

Karen Merritt, Patient Advocate-Advocates for Universal DPD, shared a post on LinkedIn:

“After the FDA and American Association for Cancer Research workshop discussing DPD deficiency testing, the FDA made a Safety Announcement to, again, raise the awareness of the labelling changes as well as the risks to patients from 5FU and capecitabine chemo if a patient is deficient of the DPD enzyme.

Testing is the ONLY way to determine if one is DPD deficient. We are still hoping for labelling updates to recommend pre-treatment DPD deficiency testing- this would be a further step towards better patient safety with this cornerstone chemotherapy.

Excerpt from safety announcement: “The FDA will continue to monitor this safety issue and evaluate the evolving landscape and impact of DPD deficiency on the safety of capecitabine and fluorouracil; additional regulatory actions will be considered.

The FDA urges patients and healthcare providers to report side effects involving capecitabine or 5-FU products to the FDA MedWatch” National Comprehensive Cancer Network (NCCN) still fails to update the guidelines to recommend pre-treatment DPD deficiency testing, yet many NCCN-member institutions have implemented universal testing such as Dana Farber Cancer Institute, Mass General and Duke Cancer Institute.”