罗拉皮坦/帕洛诺塞:首次获得批准
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罗拉皮坦/帕洛诺塞已在中国批准用于预防化疗引起的恶心和吐. 这种固定剂量组合向神经素-1和5-HT3受体,以进行有效的治疗.
科学领域:
- 药理学 药理学是指药理学的学科.
- 瘤科 支持性护理
背景情况:
- 化疗诱导的恶心和吐 (CINV) 仍然是接受癌症治疗的患者面临的重大挑战.
- 神经-1 (NK-1) 受体对抗剂和5-基三胺-3 (5-HT3) 受体对抗剂是管理CINV的关键类别.
研究的目的:
- 总结一下福斯罗拉皮坦/帕洛诺塞 (Ritanine®) 的发展里程碑.
- 为了突出该药物在中国首次获得预防CINV的批准.
主要方法:
- 对罗拉皮坦/帕洛诺塞的临床前和临床发展数据的审查.
- 分析中国的监管提交和审批流程.
主要成果:
- 罗拉皮坦 (Fosrolapitant) 是一种新型NK-1受体对抗剂前药物,与二代5-HT3受体对抗剂帕洛诺塞 (palonosetron) 形成了一种固定剂量组合.
- 2025年5月29日,福斯罗拉皮坦/帕洛诺塞在中国获得了首个营销批准.
- 该批准是用于预防与成年人高度发性化疗相关的急性和延迟的恶心和吐.
结论:
- 罗拉皮坦/帕洛诺塞代表了CINV管理的重大进步.
- 中国的批准标志着这一新型固定剂量组合疗法的关键里程碑.
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