OnCo
drugsProductApproved2021🇪🇺🇬🇧

Tivozanib

Tivozanib is a highly selective VEGF-receptor pill for kidney cancer after two or more prior treatments, notable for its tolerability and for a trial that closed the door on immunotherapy rechallenge.

TIVO-3 (2019): PFS 5.6 vs 3.9 months vs sorafenib in third line and beyond; FDA approval March 2021. TiNivo-2 (2024-26): adding nivolumab gave no benefit after prior IO. AVEO, acquired by LG Chem in 2023.

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Tivozanib
PubChem
Mechanism, step by step
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1.Oral dosing 3 weeks on / 1 off

Modality
Small-molecule kinase inhibitor (VEGFR)
Mechanism
Selective VEGFR1-3 inhibitor with low off-target kinase activity.
Brand / code
Fotivda
Dosing & schedule
Route
Oral
Schedule
1.34 mg daily, 21 days on / 7 days off
Monitoring
Blood pressure, thyroid, 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).

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. Two or more prior systemic therapies for RCC documented.

Assistance programmes

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 TA512 · 2018SMC: accepted
Appraised for
First-line advanced RCC
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA512 · SMC advice: tivozanib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2021Relapsed/refractory advanced RCC after ≥2 prior systemic therapies

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Hypertension
44%
Fatigue
43%
Diarrhoea
33%
Hand-foot syndrome
15%

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

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Recruiting now (live from ClinicalTrials.gov)

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

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Landmark trials in OnCo

Latest papers

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Literature trend19 papers in the last 12 months+19% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Tivozanib" OR ABSTRACT:"Tivozanib" OR TITLE:"Fotivda" OR ABSTRACT:"Fotivda") 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 Tivozanib, not a curated reading list.

Connected

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