MedPath

Sunitinib

Generic Name
Sunitinib
Brand Names
Sutent, Sunitinib Accord
Drug Type
Small Molecule
Chemical Formula
C22H27FN4O2
CAS Number
557795-19-4
Unique Ingredient Identifier
V99T50803M

Overview

Sunitinib is a small-molecule multi-targeted receptor tyrosine kinase (RTK) inhibitor. On January 26, 2006, the agent was formally approved by the US FDA for the indications of treating renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST). For these purposes, sunitinib is generally available as an orally administered formulation. Sunitinib inhibits cellular signaling by targeting multiple RTKs. These include all platelet-derived growth factor receptors (PDGF-R) and vascular endothelial growth factor receptors (VEGF-R). Sunitinib also inhibits KIT (CD117), the RTK that drives the majority of GISTs. In addition, sunitinib inhibits other RTKs including RET, CSF-1R, and flt3.

Background

Sunitinib is a small-molecule multi-targeted receptor tyrosine kinase (RTK) inhibitor. On January 26, 2006, the agent was formally approved by the US FDA for the indications of treating renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST). For these purposes, sunitinib is generally available as an orally administered formulation. Sunitinib inhibits cellular signaling by targeting multiple RTKs. These include all platelet-derived growth factor receptors (PDGF-R) and vascular endothelial growth factor receptors (VEGF-R). Sunitinib also inhibits KIT (CD117), the RTK that drives the majority of GISTs. In addition, sunitinib inhibits other RTKs including RET, CSF-1R, and flt3.

Indication

Sunitinib is indicated for the following conditions:

Associated Conditions

  • Gastrointestinal Stromal Tumor (GIST)
  • Renal Cell Carcinoma (RCC)
  • Renal Cell Carcinoma Recurrent
  • Unresectable, locally advanced Progressive Neuroendocrine Tumors of pancreatic origin
  • Unresectable, metastatic Progressive Neuroendocrine Tumors of pancreatic origin

Clinical Trials

View More Clinical Trials

Sign in to access the complete clinical trial database with detailed study information.

Title
Posted
Study ID
Phase
Status
Sponsor
Cisplatin or Carboplatin, and Etoposide With or Without Sunitinib Malate in Treating Patients With Extensive-Stage Small Cell Lung Cancer
2007/03/28
NCT00453154
Phase 1
Completed
National Cancer Institute (NCI)
Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
2007/03/28
NCT00453310
Phase 2
Completed
Memorial Sloan Kettering Cancer Center
Sunitinib in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia
2007/03/22
NCT00451048
Phase 2
Completed
National Cancer Institute (NCI)
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
2007/03/08
NCT00444795
N/A
Completed
Pfizer
Phase 2 Study of Panzem® NCD Alone and Combined With Sunitinib Malate in Patients With Metastatic Renal Cell Carcinoma
2007/03/07
NCT00444314
Phase 2
Completed
CASI Pharmaceuticals, Inc.
A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.
2007/03/06
NCT00443534
Not Applicable
Completed
Pfizer
Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients
2007/02/21
NCT00437372
Phase 1
Completed
Sidney Kimmel Cancer Center at Thomas Jefferson University
A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer
2007/02/15
NCT00435409
Phase 3
Completed
Pfizer
A Study of Sunitinib in Combination With Bevacizumab and Paclitaxel in Previously Untreated Patients With Metastatic Breast Cancer (SABRE-B)
2007/02/13
NCT00434356
Phase 2
Terminated
Genentech, Inc.
A Study of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer (SABRE-L)
2007/02/13
NCT00434226
Phase 2
Terminated
Genentech, Inc.

FDA Drug Approvals

View More FDA Approvals

Sign in to access additional FDA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

View More EMA Approvals

Sign in to access additional EMA-approved drug information with detailed regulatory data.

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

View More HSA Approvals

Sign in to access additional HSA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

View More NMPA Approvals

Sign in to access additional NMPA-approved drug information with detailed regulatory data.

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

View More PPB Approvals

Sign in to access additional PPB-approved drug information with detailed regulatory data.

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

View More TGA Approvals

Sign in to access additional TGA-approved drug information with detailed regulatory data.

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy