NDAORALCAPSULEPriority Review
Approved
Jan 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
SUTENT (sunitinib malate) by Viatris is (rtks), some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic progression of cancer. First approved in 2006.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SUTENT (sunitinib malate) is an oral small-molecule receptor tyrosine kinase (RTK) inhibitor approved in 2006 for the treatment of gastrointestinal stromal tumor (GIST) and renal cell carcinoma. It works by inhibiting multiple RTKs including PDGFR, VEGFR, KIT, FLT3, CSF-1R, and RET, thereby blocking tumor growth, angiogenesis, and metastatic progression. The drug represents a landmark multi-targeted kinase inhibitor with activity across >80 kinases.
$0.007BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D presence; legacy brand team likely focused on transition planning and retention strategies.
Mechanism of Action
(RTKs), some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic progression of cancer. Sunitinib was evaluated for its inhibitory activity against a variety of kinases (>80 kinases) and was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRα…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Bioequivalence Study of Sunitinib Malate Capsules.
Started Dec 2018
24 enrolled
Gastrointestinal Stromal TumorsRenal Cell CarcinomaPancreatic Neuroendocrine Tumor
Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal Cell Carcinoma
Started May 2018
32 enrolled
Malignant Neoplasms of Urinary TractRenal Cell CarcinomaChromophobe Renal Cell Carcinoma+6 more
Evaluation Of The Impact Of A Call Center In Management Of Metastatic And/Or Advanced Renal Cell Carcinoma Patients Treated With Sunitinib (Sutent) In First Line
Started Oct 2015
70 enrolled
Metastatic/Advanced Renal Cell Carcinoma
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma
Started Nov 2014
210 enrolled
Ciliary Body and Choroid Melanoma, Medium/Large SizeCiliary Body and Choroid Melanoma, Small SizeIris Melanoma+9 more
Study Of The Impact Of Inlyta In 2nd Line On The Treatment Outcomes Of mRCC Patients Treated With Sutent In 1st Line In The Real Life Setting
Started Oct 2014
554 enrolled
Metastatic Renal Cell Carcinoma (mRCC)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.