Fluorouracil (5-FU)
The 1957 chemotherapy that remains the backbone of treatment for bowel, stomach, pancreatic, anal, head and neck and breast cancers, and as a cream for skin precancers.
Heidelberger (1957). Infusional 5-FU with leucovorin is the core of FOLFOX/FOLFIRI/FOLFIRINOX, chemoradiation (rectal, anal, oesophageal, pancreatic, head and neck), and adjuvant colon therapy; capecitabine is its oral prodrug. DPYD genotyping before use is now recommended (EMA 2020; FDA label 2024). Topical 5-FU treats actinic keratosis and superficial BCC.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS J9190. When 5-FU is infused over 46 hours through an ambulatory pump at home, the drug and pump are paid under the Part B durable medical equipment benefit. Topical fluorouracil (Efudex) for skin lesions is Part D.
- Commercial insurance
- covered on label
Multi-source generic; covered under the medical benefit without prior authorisation in most plans, as part of standard regimens.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Notes
- Generic backbone of colorectal, gastric, pancreatic, breast and head and neck regimens for 60 years; funded routinely. NHS England has required DPYD testing before fluoropyrimidines since 2020.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE search: fluorouracil. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 1962 | Colorectal, breast, gastric and pancreatic adenocarcinoma |
| US | 1970 | Topical: actinic keratosis and superficial basal cell carcinoma |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Fluorouracil" OR ABSTRACT:"Fluorouracil" OR TITLE:"5-FU" OR ABSTRACT:"5-FU" OR TITLE:"Adrucil" OR ABSTRACT:"Adrucil" OR TITLE:"Efudex" OR ABSTRACT:"Efudex") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Fluorouracil (5-FU), not a curated reading list.
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