Multi-target tyrosine kinase inhibitor – VEGFR, PDGFR, c-KIT, FLT3, RET
ATC code: L01EK02 (Sunitinib)
Brand names
Sutent, Sunitinib Dr. Reddy's, Sunitinib Accord, Sunitinib Mylan
Sunitinib is an oral competitive inhibitor of the ATP-binding site of multiple tyrosine kinases: VEGFR-1, 2, 3 (antiangiogenic), PDGFR-α and β (antiproliferative), c-KIT (antiproliferative in GIST), FLT3 (antiproliferative in AML), RET (in medullary thyroid cancer). The active metabolite SU12662 has the same profile. T½ parent 40-60 h, metabolite 80-110 h.
Second line
Gastrointestinal stromal tumor (GIST) in adults after progression on imatinib or imatinib intolerance. Per ESMO 2022 and SEOM 2023 – second-line. Dose: 50 mg orally once daily on the 4/2 schedule or 37.5 mg continuous daily dosing. Efficacy depends on KIT/PDGFRA mutation subtype.
Sources
First line
Advanced and/or metastatic renal cell carcinoma in adults. Per ESMO 2024 and SEOM 2023, in favorable or intermediate IMDC risk, sunitinib remains an option in first-line, especially when immunotherapy combinations are unavailable or contraindicated. Dose: 50 mg orally once daily for 4 weeks followed by 2 weeks off (4/2 schedule). About 47% partial or complete responses; median PFS 11 months.
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Contraindicated. Embryotoxicity confirmed in animal models. Effective contraception during therapy and for 4 weeks after.
Contraindicated. Drug and metabolites pass into milk.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Sunitinib is evaluated for the following indications with varying evidence strength: Renal cell carcinoma (evidence tier A), Gastrointestinal stromal tumor (evidence tier A). See the full indication matrix with dosing and citations above on this page.
Common side effects of Sunitinib (≥ 1 in 100): Fatigue, Diarrhea, nausea, vomiting, Stomatitis and mucositis, Yellow-gray skin discoloration, Hand-foot syndrome, Dysgeusia. See the Safety section for uncommon and serious reactions.
FDA category D. Contraindicated. Embryotoxicity confirmed in animal models. Effective contraception during therapy and for 4 weeks after.
Contraindicated. Drug and metabolites pass into milk.
Sunitinib is contraindicated in: Hypersensitivity; Pregnancy and breastfeeding; Severe hepatic impairment. Full list in the Safety section.