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SUNITINIB MALATE
SUNITINIB MALATE is a drug. It is currently FDA-approved (first approved 2006).
Sunitinib malate is a small molecule used in the treatment of various cancers, including advanced biliary tract adenocarcinoma, metastatic renal cell carcinoma, and urothelial carcinoma. It has been studied as a treatment option in combination with other drugs, such as sorafenib and temsirolimus, in clinical trials for these conditions.
At a glance
| Generic name | SUNITINIB MALATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2006 |
Approved indications
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
- Fatigue
- Diarrhea
- Mucositis/stomatitis
- Nausea
- Decreased appetite/anorexia
- Vomiting
- Abdominal pain
- Hand-foot syndrome
- Hypertension
- Bleeding events
- Dysgeusia/altered taste
- Dyspepsia
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:
- SUNITINIB MALATE CI brief — competitive landscape report
- SUNITINIB MALATE updates RSS · CI watch RSS
Frequently asked questions about SUNITINIB MALATE
What is SUNITINIB MALATE?
When was SUNITINIB MALATE approved?
What development phase is SUNITINIB MALATE in?
What are the side effects of SUNITINIB MALATE?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing