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　　FDA（美國食品藥品管理局）11月22日宣布，索拉非尼的核準適應癥擴大，將晚期分化型甲狀腺癌納入其中。

　　根據處方信息，這種激酶抑制劑獲準用于治療“放射活性碘難以治愈的局部復發(fā)或轉移性、進(jìn)展性分化型甲狀腺癌。”

　　這項在6個(gè)月內完成的加速審批的依據是一項在417例對放射活性碘治療無(wú)反應的局部復發(fā)或轉移性、進(jìn)展性分化型甲狀腺癌患者中進(jìn)行的研究。這些受試者隨機接受索拉非尼(多吉美)400 mg或安慰劑每日2次治療。

　　結果顯示，索拉非尼組和安慰劑組的中位無(wú)進(jìn)展生存期分別為10.8和5.8個(gè)月，差異為41%，具有統計學(xué)意義。FDA指出，與治療相關(guān)的最常見(jiàn)的不良反應包括腹瀉、疲勞、感染、脫發(fā)、手足皮膚反應、皮疹、體重減輕、食欲下降、惡心、胃腸道與腹部疼痛以及高血壓。此外，聲明指出，可加速甲狀腺癌進(jìn)展的促甲狀腺激素“在多吉美治療期間可能更易升高，需要調整甲狀腺激素替代治療”。

　　索拉非尼(多吉美)由拜耳制藥公司生產(chǎn)，2005年獲準用于治療晚期腎細胞癌，2007年獲準用于治療無(wú)法切除的肝細胞癌。

　　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.