The tyrosine kinase inhibitor pazopanib received a conditional approval for the treatment of advanced kidney cancer from the European Commission on June 15. The clearance for the European market came about 7 months after the drug was approved in the United States.
The product was approved for the first-line treatment of advanced renal cell carcinoma, and for patients who have received prior cytokine therapy for advanced disease.
GlaxoSmithKline (GSK) said it plans to launch pazopanib, marketed as Votrient, as quickly as possible in Europe.
The product was granted a conditional approval because regulators said the benefit to public health of immediate availability outweighed the risks associated with awaiting additional data requirements. However, the commission still wants to see comparative efficacy data evaluating pazopanib to sunitinib head-to-head. A lack of comparative efficacy data in the crowded renal cell carcinoma arena has made it difficult for physicians, patients and payers to work out which drugs are best for which patients.
However, some comparative studies are underway. GSK is conducting a phase III study, COMPARZ, comparing the safety and efficacy of pazopanib head-to-head against sunitinib, also a tyrosine kinase inhibitor. That study was initiated in August 2008, and is still enrolling patients. GSK recently initiated a second trial, PISCES, in February that is evaluating patient preferences between the two drugs.
In a phase III trial, pazopanib significantly improved progression-free survival (PFS) in patients pretreated with cytokine. PFS was a median 9.2 months in patients treated with pazopanib and 4.2 months in placebo-treated patients. In treatment-naive patients, PFS was 11.1 months in patients who received pazopanib and 2.8 months in those on placebo.
GSK launched Votrient in November 2009 in the United States for the treatment of advanced renal cell carcinoma following approval by the U.S. Food and Drug Administration, which included a “black box” warning about severe and fatal hepatotoxicity.
Elsevier Global Medical News and “The Pink Sheet” are published by Elsevier.
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6月15日，欧盟委员会附条件批准酪氨酸激酶抑制剂帕唑帕尼(pazopanib)用于晚期肾癌的治疗。这是继该药在美国获批后大约7个月又成功打入欧洲市场。
该产品获批用于晚期肾细胞癌的一线治疗，也可用于先前因晚期疾病而接受过细胞因子治疗的患者。
葛兰素史克(GSK)表示，公司计划尽快将帕唑帕尼推入欧洲市场，帕唑帕尼的商品名为Votrient。
该产品之所以获得了附条件批准，是因为监管方认为立即批准该药将给公众健康带来的效益大于继续等待其他数据将会产生的风险。但欧盟委员会仍希望看到直接比较帕唑帕尼与舒尼替尼(sunitinib)的疗效对照数据。肾细胞癌的治疗药物众多，但又缺乏相应的疗效对照数据，故医生、患者和费用支付方难以确定最适合患者的药物。
不过，一些对照试验已经启动。GSK目前正在开展一项名为COMPARZ 的III期试验，旨在直接比较帕唑帕尼与另一种酪氨酸激酶抑制剂舒尼替尼的安全性和疗效。这项试验已于2008年8月正式启动，目前仍在进行患者招募工作。GSK近期还启动了第二项试验，即于今年2月开始的PISCES试验，目的是评价患者对这两种药物的偏好。
一项III期试验表明，对于先前接受过细胞因子治疗的患者，帕唑帕尼可显著延长患者的无进展生存期(PFS)。在接受了帕唑帕尼治疗的患者中，中位PFS为9.2个月，而安慰剂组患者仅为4.2个月。对于从未接受过治疗的患者，接受了帕唑帕尼治疗的患者中位PFS为11.1个月，而安慰剂组患者仅为2.8个月。
在获得美国食品药品管理局(FDA)的批准后，GSK于2009年11月在美国市场推出了晚期肾细胞癌治疗药物Votrient。FDA要求GSK在Votrient的产品说明书中注明一条关于重度和致命性肝脏毒性的“黑框警告”。
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