Axitinib
Axitinib is a selective VEGF-receptor pill, now given mainly with pembrolizumab or avelumab as first-line kidney cancer treatment.
AXIS (2011): PFS 6.7 vs 4.7 months vs sorafenib in second line. Partner in KEYNOTE-426 (pembrolizumab, OS benefit) and JAVELIN Renal 101 (avelumab, PFS benefit). Short half-life allows titration and rapid washout for immune toxicity management.
1.Oral, twice-daily dosing with short half-life
- Route
- Oral
- Schedule
- 5 mg twice daily; titrate to 7 then 10 mg if tolerated (no hypertension)
- Dose modifications
- Hold for hypertension crisis, proteinuria, or to distinguish immune from TKI hepatitis
- Monitoring
- Blood pressure, thyroid, urine protein, liver enzymes
- 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). Generic axitinib entered in 2025.
- 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. Usually paired with pembrolizumab or avelumab (Part B).
- Assistance programmes
- Pfizer Oncology Together
- Pfizer RxPathways
- 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 RCC after failure of prior systemic treatment
- Notes
- With pembrolizumab first-line: TA692 (2021).
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA333 · SMC advice: axitinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2012 | Advanced RCC after one prior systemic therapy |
| US | 2019 | First-line advanced RCC with pembrolizumab or avelumab |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Hypertension | 40% | — |
| Diarrhoea | 55% | — |
| Fatigue | 40% | — |
| Dysphonia | 30% | — |
| Hand-foot syndrome | 28% | — |
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:"Axitinib" OR ABSTRACT:"Axitinib" OR TITLE:"Inlyta" OR ABSTRACT:"Inlyta") 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 Axitinib, not a curated reading list.
Pages like this
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