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欧盟EMA调整多种抗肿瘤药物的适应证和禁忌证

2011-11-30 MedSci原创 MedSci原创

11月18日,欧洲药品管理局(EMA)建议批准甲状腺癌治疗药物凡德他尼(vandetanib)的上市申请,同时还批准了另外两种抗肿瘤药物西妥昔单抗(cetuximab)和曲妥珠单抗(trastuzumab)的新增适应证。 作为一种可有效对抗RET(转染过程中重排)原癌基因、血管内皮生长因子和表皮生长因子受体的口服蛋白激酶抑制剂,凡德他尼(由阿斯利康公司开发)将获准在所有欧盟国家上市,用于进展性或

11月18日,欧洲药品管理局(EMA)建议批准甲状腺癌治疗药物凡德他尼(vandetanib)的上市申请,同时还批准了另外两种抗肿瘤药物西妥昔单抗(cetuximab)和曲妥珠单抗(trastuzumab)的新增适应证。

作为一种可有效对抗RET(转染过程中重排)原癌基因、血管内皮生长因子和表皮生长因子受体的口服蛋白激酶抑制剂,凡德他尼(由阿斯利康公司开发)将获准在所有欧盟国家上市,用于进展性或症状性不可切除局部晚期或转移性甲状腺髓样癌 (MTC)患者的治疗。美国食品药品管理局(FDA)也于今年4月批准了相同的适应证。

不过,EMA也提醒道,对于RET突变状态为阴性或不明的患者,这种药物的疗效可能不太理想。此外,EMA还建议只让那些在治疗这类癌症方面经验丰富的医生来开具凡德他尼,由于已知QT间期延长是该药的副作用之一,所以使用该药的医生必须得善于判读心电图。

除了批准凡德他尼之外,EMA还在同一天批准了西妥昔单抗(由默克公司开发)的新增适应证。西妥昔单抗现有的适应证包括:单用或与以伊立替康为基础的化疗联用治疗KRAS野生型转移性结直肠癌患者;与放疗或化疗联用治疗头颈鳞状细胞癌患者。新增的适应证为:与FOLFOX(亚叶酸、氟尿嘧啶和奥沙利铂)化疗方案联用作为EGFR阳性、KRAS野生型转移性结直肠癌患者的一线治疗。与此同时,EMA还宣布了西妥昔单抗的一项新增禁忌证:禁用于KRAS突变阳性或状态不明的转移性结直肠癌患者。

此外,EMA当天还批准了曲妥珠单抗(由罗氏公司开发)的新增适应证,即在现有HER2阳性早期乳腺癌适应证的基础上还推荐其先与新辅助化疗联用,再单用辅助药物曲妥珠单抗治疗局部进展(包括炎症性)疾病或直径大于2 cm的肿瘤。

出于安全性方面的担忧,EMA决定暂停销售所有含丁咯地尔(buflomedil)的药物,丁咯地尔是一种用于治疗周围动脉闭塞性疾病(PAOD)的血管活性药物,自上个世纪70年代就开始在欧洲使用。2011年2月法国药品管理局出于对丁咯地尔严重且致命性副作用的担忧暂停了含丁咯地尔的所有药物的销售,也引发了全欧洲对该药的重新审视。EMA的评审结论是:“治疗剂量与可能给老年患者或患有肾病等某些合并症的患者造成危害的剂量之间相差不大,而这类情况在PAOD患者中相当常见。加之该药的疗效有限,因此有充分的理由暂停其在所有欧盟国家的销售。”

EMA还更新了甲磺酸达比加群酯(dabigatran etexilate,由勃林格殷格翰公司开发)的安全性审查进度,这是一种用于预防髋关节和膝关节置换术后出现静脉血栓栓塞事件的药物,今年8月在欧盟国家又获准用于非瓣膜性房颤患者卒中和全身性栓塞的预防。由于接受了甲磺酸达比加群酯治疗的部分患者出现了致命性出血事件,因此上个月EMA对该药的处方信息提出了一些修改意见,建议在开始治疗前先筛查患者是否存在肾功能损害,对于老年患者以及有已知或潜在肾功能损害的患者应密切监测。EMA尚未要求厂家采取进一步的行动,不过仍在继续监测该药的出血报告。EMA称,目前已得知256例与达比加群酯使用相关的严重致命性出血事件,其中21例发生在欧盟国家。

11月18日,EMA还:

• 批准了奈帕芬胺(nepafenac,由爱尔康开发)的新增适应证,可以用于减轻糖尿病患者白内障手术后的疼痛和炎症,以及降低糖尿病患者白内障手术后出现黄斑水肿的风险。

• 批准了干扰素β-1a(由默克公司开发)的新增适应证,可以用于曾发生脱髓鞘事件且处于活性炎性过程、排除了其他诊断、多发性硬化风险较高的患者。

• 建议批准地氯雷他定(desloratadine)和多西他赛(docetaxel)仿制药的上市申请。

• 拒绝重新考虑抗焦虑和抗抑郁药物度洛西汀(duloxetine,由礼来公司开发)的生产商提出的新增适应证申请。EMA之前拒绝批准该药用于没有规律服用非甾体类抗炎药(NSAID)的患者中重度慢性躯体痛的治疗,EMA认为没有充分的证据证明度洛西汀对这类患者有益,或能长时间维持疗效,或可以安全用于老年患者。

• 公布了对含阿片样药物福尔可定(pholcodine)的镇咳药的审查结果,之前有人担心这类药物可能会令患者对手术期间使用的神经肌肉阻断剂出现过敏反应。EMA的结论是:没有充分证据证明这一相关性,仍然认为这类药物的效益大于其风险。

EMA的所有决定只有在通过了欧盟委员会的批准后才具有法律效力。

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    2011-12-02 fengyi812
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