Approval summary: Sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma
Approval summary: Sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma
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DOI：
10.1158/1078-0432.ccr-06-2328
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发表时间：
2007-03-01
影响因子：
11.5
通讯作者：
Pazdur, Richard
中科院分区：
文献类型：
--
作者：
Goodman, Vicki L.;Rock, Edwin P.;Pazdur, Richard
目的：描述美国食品药品监督管理局（FDA）对苹果酸舒尼替尼（Sutent）的审评和批准。舒尼替尼在疾病进展或对甲磺酸伊马替尼（格列卫）不耐受后获得常规批准用于治疗胃肠道间质瘤（GIST）。此外，舒尼替尼获得加速批准用于治疗晚期肾细胞癌。实验设计：对于GIST适应症，FDA审查了来自随机安慰剂对照试验的数据，并获得了来自单臂研究的支持性证据。对于晚期肾细胞癌的适应症，FDA审查了来自两项单组研究的数据，这些研究的患者为难治性转移性肾细胞癌患者。结果：在伊马替尼难治性或不耐受性GIST患者中，舒尼替尼治疗患者的肿瘤进展时间上级安慰剂治疗患者。舒尼替尼治疗患者的中位肿瘤进展时间为27.3周，而安慰剂治疗患者为6.4周（P < 0.0001）。在6.8%的舒尼替尼治疗患者中观察到部分缓解。在转移性肾细胞癌患者中，舒尼替尼治疗的部分缓解率分别为25.5%（95%置信区间，17.5，34.9）和36.5%（95%置信区间，24.7，49.6）。中位缓解持续时间分别为27.1周和54周。舒尼替尼最常见的不良反应包括腹泻、粘膜炎、皮肤异常和味觉改变。左心室射血分数和严重高血压的减少也更常见于舒尼替尼治疗patients.Conclusions：2006年1月26日，FDA批准舒尼替尼用于治疗伊马替尼难治性或不耐受性GIST患者。
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.