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在欧洲,人用药品委员会建议授权给用于甲状腺髓样癌治疗的cabozantinib上市许可的批准。人用药品委员会认为,药物警戒计划将作为此次批准的组成部分之一实施。该药品完整的适应证是对于进展期的,不能手术切除的,局部晚期或者转移性的甲状腺髓样癌患者治疗时使用。在对此类患者的临床试验中,与安慰剂进行对比,cabozantinib可改善无进展生存期。
In Europe, the Human Medicines Board recommends approval of a marketing authorization for cabozantinib for the treatment of medullary thyroid cancer. The Commission on Human Medicines believes that the pharmacovigilance program will be implemented as part of this approval. The complete indications for this drug are for use in patients with advanced, unresectable, locally advanced or metastatic thyroid medullary carcinoma. In a clinical trial of these patients, cabozantinib improved progression-free survival compared with placebo.