Food and drug administration drug approval summary: Sunitinib malate for the treatment of gastrointestinal stromal tumor and advanced renal cell carcinoma
Food and drug administration drug approval summary: Sunitinib malate for the treatment of gastrointestinal stromal tumor and advanced renal cell carcinoma
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DOI：
10.1634/theoncologist.12-1-107
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发表时间：
2007-01-01
期刊：
影响因子：
5.8
通讯作者：
Pazdur, Richard
中科院分区：
文献类型：
--
作者：
Rock, Edwin P.;Goodman, Vicki;Pazdur, Richard
2006年1月26日，舒尼替尼（索坦）获得常规批准，作为单一疗法，用于治疗甲磺酸伊马替尼（格列卫）疾病进展或不耐受的胃肠道间质瘤患者。舒尼替尼治疗患者的肿瘤进展时间（TTP）优于安慰剂治疗患者。舒尼替尼治疗患者的中位 TTP 为 27.3 周，而安慰剂治疗患者为 6.4 周 (p < .0001)。在接受舒尼替尼治疗的患者中观察到 6.8% 的部分缓解，而接受安慰剂治疗的患者则没有观察到部分缓解。舒尼替尼还于 2006 年 1 月 26 日获得加速批准，作为治疗晚期肾细胞癌 (RCC) 的单一疗法。在两项舒尼替尼治疗转移性 RCC 患者的单臂试验中，25.5%（95% 置信区间 [CI]，17.5，34.9）和 36.5%（95% CI，24.7，49.6）的患者观察到部分缓解。两项试验的中位缓解持续时间分别为 27.1 周（95% CI，24.4，无法计算）和 54 周（95% CI，34.3，70.1）。舒尼替尼治疗患者中出现的治疗不良事件包括腹泻、粘膜炎、皮肤异常、味觉改变、电解质异常、高血压和左心室射血分数降低。舒尼替尼对于已有心脏异常的患者的心脏安全性仍不清楚。根据非临床发现，医生在开舒尼替尼处方时应监测承受手术、创伤或严重感染等应激源的患者是否存在肾上腺功能不全。舒尼替尼与已知的 CYP3A4 诱导剂或抑制剂联合用药时应谨慎。
On January 26, 2006, sunitinib (Sutent) received regular approval as monotherapy for the treatment of patients with gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate (Gleevec). Time-to-tumor progression (TTP) of sunitinib-treated patients was superior to that of placebo-treated patients. Median TTP of sunitinib-treated patients was 27.3 weeks, compared with 6.4 weeks for placebo-treated patients (p < .0001). Partial responses were observed in 6.8% of sunitinib-treated patients and no placebo-treated patients. Sunitinib also received accelerated approval on January 26, 2006, as monotherapy for treatment of advanced renal cell carcinoma (RCC). In two single-arm trials of sunitinib in patients with metastatic RCC, partial responses were observed in 25.5% (95% confidence interval [CI], 17.5, 34.9) and 36.5% (95% CI, 24.7, 49.6) of patients. Median response durations in the two trials were 27.1 weeks (95% CI, 24.4, incalculable) and 54 weeks (95% CI, 34.3, 70.1). Treatment-emergent adverse events in sunitinib-treated patients included diarrhea, mucositis, skin abnormalities, altered taste, electrolyte abnormalities, hypertension, and diminution in left ventricular ejection fraction. Cardiac safety of sunitinib in patients with preexisting cardiac abnormalities remains unknown. Based on nonclinical findings, physicians prescribing sunitinib should monitor for adrenal insufficiency in patients who undergo stressors such as surgery, trauma, or severe infection. Caution should be exercised when administering sunitinib in combination with known CYP3A4 inducers or inhibitors.