贝伐珠单抗新适应证有望获EMA批准

2012-10-26 奎妮 中国医学论坛报

  9月20日,欧洲药品管理局(EMA)人用药品委员会(CHMP)宣布对正在申请的贝伐珠单抗新适应证持积极肯定的意见,新适应证为,贝伐珠单抗与卡铂和吉西他滨联用适用于首次复发的铂敏感性上皮性卵巢癌、输卵管癌和原发性腹膜癌患者,这些患者既往未接受过贝伐珠单抗、其他血管内皮生长因子(VEGF)抑制剂或VEGF受体靶向药物治疗。更新产品特性概要(SmPC)将在修订版CHMP欧盟公共评估报告(EPAR)中

  9月20日,欧洲药品管理局(EMA)人用药品委员会(CHMP)宣布对正在申请的贝伐珠单抗新适应证持积极肯定的意见,新适应证为,贝伐珠单抗与卡铂和吉西他滨联用适用于首次复发的铂敏感性上皮性卵巢癌、输卵管癌和原发性腹膜癌患者,这些患者既往未接受过贝伐珠单抗、其他血管内皮生长因子(VEGF)抑制剂或VEGF受体靶向药物治疗。更新产品特性概要(SmPC)将在修订版CHMP欧盟公共评估报告(EPAR)中发表,并可在欧委会批准上市销售许可变更后查询。

  目前在欧盟批准的适应证中,贝伐珠单抗可应用于转移性结直肠癌、转移性乳腺癌、晚期非小细胞肺癌、肾细胞癌及卵巢癌的一线治疗。



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    2012-10-28 fengyi812
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