FDA（美国食品药品管理局）11月22日宣布，索拉非尼的核准适应症扩大，将晚期分化型甲状腺癌纳入其中。

　　根据处方信息，这种激酶抑制剂获准用于治疗“放射活性碘难以治愈的局部复发或转移性、进展性分化型甲状腺癌。”

　　这项在6个月内完成的加速审批的依据是一项在417例对放射活性碘治疗无反应的局部复发或转移性、进展性分化型甲状腺癌患者中进行的研究。这些受试者随机接受索拉非尼(多吉美)400 mg或安慰剂每日2次治疗。

　　结果显示，索拉非尼组和安慰剂组的中位无进展生存期分别为10.8和5.8个月，差异为41%，具有统计学意义。FDA指出，与治疗相关的最常见的不良反应包括腹泻、疲劳、感染、脱发、手足皮肤反应、皮疹、体重减轻、食欲下降、恶心、胃肠道与腹部疼痛以及高血压。此外，声明指出，可加速甲状腺癌进展的促甲状腺激素“在多吉美治疗期间可能更易升高，需要调整甲状腺激素替代治疗”。

　　索拉非尼(多吉美)由拜耳制药公司生产，2005年获准用于治疗晚期肾细胞癌，2007年获准用于治疗无法切除的肝细胞癌。

　　原文

　　By: ELIZABETH MECHCATIE, Internal Medicine News Digital Network
　　Sorafenib’s approval has been expanded to include late-stage differentiated thyroid cancer, the Food and Drug Administration announced on Nov. 22.

　　The kinase inhibitor was approved for the treatment of "locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment," according to the prescribing ***rmation.

　　The expedited approval –completed in 6 months – was based on a study of 417 people with locally recurrent or metastatic, progressive differentiated thyroid cancer that had not responded to radioactive iodine treatment. Subjects were randomized to 400 mg of sorafenib twice a day or placebo. The median progression-free survival was 10.8 months among those on sorafenib and 5.8 months among those on placebo, a statistically significant 41% difference.

　　Diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, and hypertension were among the most common adverse effects associated with treatment, according to the FDA. In addition, thyroid stimulating hormone, which can promote thyroid cancer, "is more likely to become elevated while on treatment with Nexavar, requiring adjustment of thyroid hormone replacement therapy," the statement said.

　　Sorafenib, marketed as Nexavar by Bayer HealthCare Pharmaceuticals was approved for treating advanced renal cell carcinoma in 2005 and for unresectable hepatocellular carcinoma in 2007.