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Sunitinib Malate (SU011248)

Sunitinib Malate (SU011248) is a Multi-targeted tyrosine kinase inhibitor Small molecule drug developed by H. Lee Moffitt Cancer Center and Research Institute. It is currently FDA-approved for Gastrointestinal stromal tumor (GIST), Metastatic renal cell carcinoma, Pancreatic neuroendocrine tumors. Also known as: Sutent, SU011248.

Sunitinib is a multi-targeted tyrosine kinase inhibitor that blocks growth factor receptors (VEGFR, PDGFR, KIT, FLT3) to inhibit tumor angiogenesis and cell proliferation.

Sunitinib Malate (SU011248) is a small molecule used to treat various types of cancer, including Renal Cell Carcinoma, Colorectal Neoplasms, and certain types of brain tumors such as Adult Anaplastic Astrocytoma, Adult Diffuse Astrocytoma, and Adult Giant Cell Glioblastoma. It is administered as a treatment intervention in clinical trials, often in combination with other therapies like mFOLFOX6 or bevacizumab.

At a glance

Mechanism of action

Sunitinib inhibits multiple receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR), and KIT, which are critical for tumor blood vessel formation and cancer cell survival. By blocking these pathways, it reduces tumor vascularity and directly suppresses cancer cell growth. This dual mechanism of anti-angiogenic and anti-proliferative activity makes it effective against multiple cancer types.

Approved indications

• Gastrointestinal stromal tumor (GIST)
• Metastatic renal cell carcinoma
• Pancreatic neuroendocrine tumors

Common side effects

• Fatigue
• Diarrhea
• Nausea
• Hand-foot skin reaction
• Hypertension
• Thrombocytopenia
• Neutropenia
• Anemia

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

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Sunitinib Malate (SU011248) CI brief — competitive landscape report
• Sunitinib Malate (SU011248) updates RSS · CI watch RSS
• H. Lee Moffitt Cancer Center and Research Institute portfolio CI

Frequently asked questions about Sunitinib Malate (SU011248)

Related

• Drug class: All Multi-targeted tyrosine kinase inhibitor drugs
• Target: All drugs targeting VEGFR, PDGFR, KIT, FLT3
• Manufacturer: H. Lee Moffitt Cancer Center and Research Institute — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Gastrointestinal stromal tumor (GIST)
• Indication: Drugs for Metastatic renal cell carcinoma
• Indication: Drugs for Pancreatic neuroendocrine tumors
• Also known as: Sutent, SU011248

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing