OnCo
drugsProductApproved2012🇪🇺🇬🇧🇯🇵🇨🇳🇦🇺

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.

Loading structure…
|
Axitinib
PubChem
Mechanism, step by step
auto-advancing · hover to pause

1.Oral, twice-daily dosing with short half-life

Modality
Small-molecule kinase inhibitor (VEGFR)
Mechanism
Potent selective VEGFR1-3 inhibitor.
Brand / code
Inlyta
Dosing & schedule
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).

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.

NICE recommendedNICE TA333 · 2015SMC: accepted
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.

Regulatory

2top

Approvals

RegionYearIndication
US2012Advanced RCC after one prior systemic therapy
US2019First-line advanced RCC with pembrolizumab or avelumab

Safety

5top
Toxicity profile
Adverse eventAny gradeGrade 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

top
ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
161 studies17 recruiting86 Phase 215 Phase 3
Search “Axitinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Axitinib
intervention: Axitinib
Open on ClinicalTrials.gov →

Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.

Landmark trials in OnCo

Latest papers

top
Literature trend163 papers in the last 12 months-5% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query 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.

Connected

9top