Regorafenib
A sorafenib successor that became the first second-line drug proven to prolong life in liver cancer (2017).
RESORCE: OS 10.6 vs 7.8 months versus placebo after sorafenib progression (HR 0.63). Also approved in refractory colorectal cancer (CORRECT) and GIST after imatinib and sunitinib (GRID). Sequencing sorafenib then regorafenib gave a median 26 months from sorafenib start.
1.Regorafenib enters tumour and vessel cells
- Route
- Oral
- Schedule
- 160 mg daily for 3 weeks of each 4-week cycle
- Dose modifications
- Start-low (80-120 mg) escalation strategies (ReDOS in CRC) improve tolerability
- 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.
- Assistance programmes
- Bayer US Patient Assistance Foundation
- 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
- Advanced HCC after sorafenib
- Notes
- GIST after imatinib and sunitinib: TA488 (2017). Metastatic colorectal cancer was not recommended.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA555 · SMC advice: regorafenib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2012 | Metastatic colorectal cancer, previously treated |
| US | 2013 | GIST after imatinib and sunitinib |
| US | 2017 | HCC previously treated with sorafenib |
| US | 2012 | Refractory metastatic colorectal cancer |
| US | 2017 | HCC after sorafenib |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Hand-foot skin reaction RESORCE | 53% | 13% |
| Hypertension RESORCE | 31% | 15% |
| Fatigue RESORCE | 40% | 9% |
| Hand-foot skin reaction Common, dose-limiting | — | — |
| Fatigue | — | — |
| Hypertension | — | — |
| Hepatotoxicity Boxed warning | — | — |
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:"Regorafenib" OR ABSTRACT:"Regorafenib" OR TITLE:"Stivarga" OR ABSTRACT:"Stivarga") 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 Regorafenib, not a curated reading list.