Approval Summary: Sunitinib for the Treatment of Imatinib Refractory or Intolerant Gastrointestinal Stromal Tumors and Advanced Renal Cell Carcinoma

Purpose: To describe the Food and Drug Administration (FDA) review and approval of sunitinib malate (Sutent). Sunitinib received regular approval for the treatment of gastrointestinal stromal tumor (GIST) after disease progression or intolerance to imatinib mesylate (Gleevec). Additionally, sunitini...

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Published in:Clinical cancer research 2007-03, Vol.13 (5), p.1367-1373
Main Authors: GOODMAN, Vicki L, ROCK, Edwin P, CHIDAMBARAM, Nallaperumal, JIANG, Janet X, SHENGHUI TANG, MAHJOOB, Kooros, JUSTICE, Robert, PAZDUR, Richard, DAGHER, Ramzi, RAMCHANDANI, Roshni P, ABRAHAM, Sophia, GOBBURU, Jogarao V. S, BOOTH, Brian P, VERBOIS, S. Leigh, MORSE, David E, CHENG YI LIANG
Format: Article
Language:English
Subjects:
Antineoplastic agents
Antineoplastic Agents - therapeutic use
Benzamides
Biological and medical sciences
Carcinoma, Renal Cell - drug therapy
Drug Approval
Drug Resistance, Neoplasm
Gastroenterology. Liver. Pancreas. Abdomen
Gastrointestinal stromal tumor
Gastrointestinal Stromal Tumors - drug therapy
Humans
Imatinib Mesylate
Indoles - therapeutic use
Kidney Neoplasms - drug therapy
Kidneys
Medical sciences
Nephrology. Urinary tract diseases
Pharmacology. Drug treatments
Piperazines - therapeutic use
Pyrimidines - therapeutic use
Pyrroles - therapeutic use
Randomized Controlled Trials as Topic
Renal cell carcinoma
Stomach. Duodenum. Small intestine. Colon. Rectum. Anus
Sunitinib
Sutent
Tumors
Tumors of the urinary system
United States
United States Food and Drug Administration
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Summary:Purpose: To describe the Food and Drug Administration (FDA) review and approval of sunitinib malate (Sutent). Sunitinib received regular approval for the treatment of gastrointestinal stromal tumor (GIST) after disease progression or intolerance to imatinib mesylate (Gleevec). Additionally, sunitinib received accelerated approval for the treatment of advanced renal cell carcinoma. Experimental Design: For the GIST indication, FDA reviewed data from a randomized, placebo-controlled trial with supportive evidence from a single-arm study. For the advanced renal cell carcinoma indication, FDA reviewed data from two single-arm studies of patients with cytokine-refractory metastatic renal cell carcinoma. Results: In patients with imatinib refractory or intolerant GIST, time-to-tumor progression of sunitinib-treated patients was superior to that of placebo-treated patients. Median time-to-tumor progression of sunitinib-treated patients was 27.3 weeks, compared with 6.4 weeks for placebo-treated patients ( P < 0.0001). Partial responses were observed in 6.8% of sunitinib-treated patients. In patients with metastatic renal cell carcinoma, partial responses were observed in 25.5% (95% confidence interval, 17.5, 34.9) and 36.5% (95% confidence interval, 24.7, 49.6) of patients treated with sunitinib. Median response durations were 27.1 and 54 weeks. The most common adverse events attributed to sunitinib included diarrhea, mucositis, skin abnormalities, and altered taste. Reductions in left ventricular ejection fraction and severe hypertension were also more common in sunitinib-treated patients. Conclusions: On January 26, 2006, the FDA approved sunitinib for the treatment of patients with imatinib refractory or intolerant GIST. Accelerated approval was granted for the treatment of advanced renal cell carcinoma.
ISSN:1078-0432
1557-3265
DOI:10.1158/1078-0432.CCR-06-2328