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Sutent (sunitinib)
Sunitinib is a small-molecule, multi-targeted receptor tyrosine kinase inhibitor that inhibits PDGFRα, PDGFRβ, VEGFR1, VEGFR2, and KIT.
Sutent (sunitinib) is a small-molecule, multi-targeted receptor tyrosine kinase inhibitor developed by Pfizer Inc. It is used to treat renal cell carcinoma, gastrointestinal stromal tumor, and pancreatic neuroendocrine tumor. Sunitinib works by inhibiting multiple receptor tyrosine kinases, including PDGFRα, PDGFRβ, VEGFR1, VEGFR2, and KIT. This mechanism allows it to inhibit tumor growth, angiogenesis, and metastatic progression. Sunitinib was the first cancer drug approved for two different indications, renal cell carcinoma and imatinib-resistant gastrointestinal stromal tumor. Its commercial significance lies in its ability to treat a range of cancers, and pipeline developments may focus on optimizing its dosing and combination therapies.
At a glance
| Generic name | sunitinib |
|---|---|
| Sponsor | Pfizer |
| Drug class | Moderate Risk QT Prolonging Agents |
| Target | 3-phosphoinositide-dependent protein kinase 1 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2006 |
Mechanism of action
Sunitinib is a small-molecule drug that works by inhibiting multiple receptor tyrosine kinases. These kinases are enzymes that play a crucial role in the growth and spread of cancer cells. By inhibiting these kinases, sunitinib can slow down or stop the growth of cancer cells. This mechanism of action is unique to sunitinib, making it a valuable treatment option for patients with certain types of cancer.
Approved indications
- Gastrointestinal Stromal Tumor (GIST)
- Advanced Renal Cell Carcinoma (RCC)
- Adjuvant Treatment of High-Risk Recurrent RCC
- Pancreatic Neuroendocrine Tumors (pNET)
Boxed warnings
- WARNING: HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib malate capsules as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib malate capsules as recommended [see Warnings and Precautions ( 5.1) ].
Common side effects
- Hepatotoxicity
- Cardiovascular Events
- QT Interval Prolongation and Torsade de Pointes
- Hypertension
- Hemorrhagic Events
- Tumor Lysis Syndrome
- Thrombotic Microangiopathy
- Proteinuria
- Dermatologic Toxicities
- Reversible Posterior Leukoencephalopathy Syndrome
- Thyroid Dysfunction
- Hypoglycemia
Drug interactions
- Strong CYP3A4 Inhibitors
- Strong CYP3A4 Inducers
- Drugs that Prolong QT Interval
Key clinical trials
- Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors (PHASE1)
- Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial (PHASE2)
- Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial (PHASE1)
- A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours (PHASE2)
- Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (PHASE2)
- Testing Sunitinib as Potentially Targeted Treatment in Cancers With cKIT Genetic Changes (MATCH - Subprotocol V) (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
- Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sutent CI brief — competitive landscape report
- Sutent updates RSS · CI watch RSS
- Pfizer portfolio CI