Clinical Implications of the FDA’s Capecitabine Boxed Warning: Integrating DPYD Testing into Oncology Practice
Key Clinical Summary
- DPYD testing is now considered standard of care, following recent US Food and Drug Administration (FDA) label updates and National Comprehensive Cancer Network (NCCN) guideline changes, requiring oncology practices to integrate testing into pre-treatment workflows to prevent severe fluoropyrimidine toxicity.
- Operational success depends on streamlined processes, including clear testing policies, reliable lab partners, standing orders, integrated electronic medical record (EMR) workflows, and automated alerts to ensure timely results and actionability.
- Clinical decision support platforms can embed DPYD results directly into oncology workflows, helping clinicians identify at-risk patients, interpret results, and apply evidence-based dosing recommendations.
As precision medicine continues to reshape oncology, the FDA’s recent update requiring DPYD testing before prescribing capecitabine marks a pivotal moment for patient safety and clinical practice. In this interview, Houda Hachad, PharmD, vice president of clinical operations at Aranscia, discusses the implications of this regulatory shift and the growing role of pharmacogenomics in cancer care. She explores the operational challenges oncology practices face, the technology solutions that can streamline implementation, and how genetic insights can prevent life-threatening toxicities while supporting more personalized treatment decisions.
Please introduce yourself by stating your name, title, organization, and relevant professional experience.
Houda Hachad, PharmD: My name is Houda Hachad. I am a PharmD by training and a clinical pharmacologist. I am the vice president of clinical operations at Aranscia, and I lead initiatives to expand our turnkey precision medicine solutions. My work focuses on aligning genomic testing with clinical decision support and workflow optimization across different constituents within the precision medicine ecosystem, namely health systems, payer networks, etc.
With the FDA now requiring DPYD testing prior to initiating capecitabine, what are the most immediate steps oncology practices should take to implement this testing as part of their standard pre-treatment workflow, particularly in community oncology settings where most patients receive care?
Dr Hachad: To provide background, this month the FDA added an important change to the capecitabine label. Capecitabine is a pro-drug for fluorouracil. This is an important medication as it is part of standard of care for many types of solid tumors. The FDA updated the black box warning, calling on the oncology community to recognize the issue of genetic variability with DPYD and the risk it puts on certain patients. The FDA is asking oncologists to order the test.
This update pushes DPYD testing to be part of standard of care. Practices across the US now need to find a pathway to order the test. Institutions must develop policies around accessing the test, find a reliable partner lab to perform it, and incorporate these orders into the existing clinical workflow, which we know can be challenging.
Most importantly, every cancer center must be ready to identify patients who need testing, ideally pre-treatment so the care team receives test results before the first dose of these medications. Identifying who can place the orders, integrating policies, documenting that results are back, and acting on those results are all critical considerations. There is a new test that is standard of care and must be incorporated. Although the FDA updated the label this month, last week the NCCN updated 3 of their guidelines—colon cancer, rectal cancer, and small bowel adenocarcinoma—to incorporate the same language regarding DPYD testing. So, this is now truly something the community must embed and implement in existing care plans.
Many oncologists cite workflow challenges—from ordering tests to receiving actionable results in time—as barriers to adoption. What specific operational or technological changes can help practices overcome these bottlenecks and make DPYD testing both routine and efficient?
Dr Hachad: With this new DPYD testing mandate, we're trying to change the behavior of busy oncologists. Oncologists often complain because some of these operations require them to perform tasks outside their clinical workflow.
One of the most important things we need to do to streamline and increase adoption is simplify the entire process. We must avoid making this a last-minute scramble. Providers should be able to access and order tests efficiently, ideally at the time of diagnosis. Streamlining the consent process and specimen collection, perhaps during the chemo visit or chemo session, is key.
Sometimes we can bundle pharmacogenomics (PGx) orders as part of existing standing orders routinely done for patients with specific cancers. Care centers need to implement these standing orders to avoid treatment delays, enable pharmacist support, and ensure that when results come back, they are received within the EMR.
Tools can be implemented to notify oncologists when results are available—alerts, notifications, discrete data integration, etc—so no order falls through the cracks and no patient misses this important safety measure. Ultimately, we need to make DPYD testing, and PGx testing overall, feel like ordering a complete blood count (CBC). Embedding clinical decision support is crucial to help clinicians act on results with clear, simple guidance rather than genetic jargon.
How can clinical decision support platforms like Aranscia’s solutions (eg, 2bPrecise®, Spesana, YouScript®) integrate DPYD results into oncologists’ workflows in real time, and what impact could this have on preventing adverse drug reactions or treatment delays?
Dr Hachad: Within the Aranscia portfolio, we have multiple offerings that are synergistic in deploying a DPYD program—a program meaning not just access to tests. Our AccessDx PGx profile already incorporates DPYD gene testing as part of a multigene panel. Results are integrated seamlessly into our clinical decision support to create actionable recommendations based on Clinical Pharmacogenetics Implementation Consortium (CPIC) and FDA guidance.
YouScript, our clinical decision support and knowledge base, provides evidence-based recommendations on what to do when an individual carries 1 or 2 variants. It can also surface other medication-related insights for oncologists.
Integration tools within 2bPrecise and Spesana embed alerts and recommendations into existing workflows. They enrich the EMR with insights on identifying patients for testing, accessing results at prescribing, and acting on those results.
Adding DPYD strengthens chemotherapy safety efforts and accelerates delivery of safe treatment. Such tools are ideal to streamline, scale, and standardize DPYD integration for every patient.
