The U.S. Food and Drug Administration (FDA) has approved an updated label for capecitabine (Xeloda) that includes a boxed warning highlighting the potential for serious adverse reactions or death in patients with complete dihydropyrimidine dehydrogenase (DPD) deficiency and recommending DPYD genetic testing prior to initiating treatment, unless immediate therapy is necessary. This update reflects growing recognition of the significant risk of severe adverse reactions or fatal toxicity in patients with certain DPYD gene variants who are treated with fluoropyrimidine drugs like capecitabine.
As an organization committed to the safety and well-being of patients receiving cancer therapy, we support the FDA's updated guidance and urge healthcare providers to integrate DPYD genetic testing into clinical practice. Identifying patients with partial or complete DPD deficiency before fluoropyrimidine treatment can guide safer dosing decisions or drug avoidance and help avoid preventable toxicities, hospitalizations, or death. This recommendation aligns with international guidelines and emerging best practices that prioritize pharmacogenetic testing as a tool for individualized care. While we recognize that urgent clinical situations may occasionally necessitate treatment before testing results are available, we affirm that patient safety must remain the guiding principle.
As this label change takes effect, we urge healthcare providers to review institutional protocols and ensure access to timely DPYD genetic testing when fluoropyrimidines are considered. We also urge insurance providers to cover DPYD tests under their plans to ensure that patients who need the tests are able to affordably access them in a timely manner. Finally, we ask that lab companies offer comprehensive assays that align with the Association for Molecular Pathology's joint consensus recommendation on the minimum set of DPYD variants that should be included on a commercial panel with standardized reporting nomenclature and reduce turn-around times for these tests to avoid delays in therapy initiation.
