Trifluridine/tipiracil
An oral chemotherapy pill for bowel cancer that has stopped responding to everything else; with bevacizumab it extends life by about three months.
Trifluridine is incorporated into DNA; tipiracil blocks its breakdown. RECOURSE (2015) showed OS 7.1 vs 5.3 months alone; SUNLIGHT (2023) showed 10.8 vs 7.5 months with bevacizumab. Also approved in gastric cancer (TAGS). Neutropenia is the main toxicity; works even after 5-FU resistance because of a different mechanism.
1.Tipiracil blocks the enzyme that would destroy trifluridine, keeping blood levels up
- Route
- Oral
- Schedule
- 35 mg/m² twice daily on days 1-5 and 8-12 of a 28-day cycle
- Dose modifications
- Delay for neutrophils <1,500 or platelets <75,000
- Monitoring
- Complete blood count before each cycle and on day 15
Source: www.accessdata.fda.gov/drugsatfda_docs/label/2023/207981s012lbl.pdf. Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
- Commercial insurance
- covered with prior authorisation
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. Plans require prior fluoropyrimidine, oxaliplatin and irinotecan for colorectal use.
- Assistance programmes
- Taiho Oncology Patient Support
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
- Appraised for
- Metastatic colorectal cancer after standard therapies
- Notes
- Metastatic gastric or GOJ cancer after 2 or more therapies: TA669 (2021). With bevacizumab (SUNLIGHT) appraised 2024.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA405 · SMC advice: trifluridine-tipiracil. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- Sept 2015ApprovalUS
RECOURSE
- Aug 2023ApprovalUS
SUNLIGHT combination
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2015 | Refractory metastatic colorectal cancer |
| US | 2019 | Refractory metastatic gastric/GEJ cancer (TAGS) |
| US | 2023 | Refractory mCRC with bevacizumab |
| Adverse event |
|---|
| Neutropenia |
| Anaemia |
| Nausea, fatigue |
Most common grade 3-4 event; febrile neutropenia uncommon. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Trifluridine/tipiracil" OR ABSTRACT:"Trifluridine/tipiracil" OR TITLE:"Lonsurf" OR ABSTRACT:"Lonsurf" OR TITLE:"TAS-102" OR ABSTRACT:"TAS-102") 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 Trifluridine/tipiracil, not a curated reading list.
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