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Open Access Article

International Medical Research Frontier. 2022; 6: (4) ; 12-19 ; DOI: 10.12208/j.imrf.20220127.

Establishment of a preliminary evaluation plan for the expanded application of a new domesticallyproduced PD-1 mAb——Taking Piamprimab as an example
新型国产PD-1单抗拓展性应用初步评价方案建立——以派安普利单抗为例

作者: 王鹏翀, 朱亚宁, 史先鹏, 雍素云, 郝瑞芳, 张鹏 *

陕西省人民医院药学部 陕西西安

*通讯作者: 张鹏,单位:陕西省人民医院药学部 陕西西安;

发布时间: 2022-09-14 总浏览量: 394

摘要

目的 分析派安普利单抗的拓展性应用情况,建立新型国产程序性死亡受体-1(PD-1)单抗的拓展性应用的初步评价方案,为临床应用提供依据和参考。方法 收集药品信息和拓展性应用循证证据,确定拓展性应用范围;检索相关指南,对于已在国外获批适应症或已得到指南推荐的拓展性应用予以推荐;筛选已获批适应症或得到指南推荐的其他同类药品,通过可替代性评价给出拓展性应用推荐意见。结果 经初步筛选,确定8种拓展性应用;通过检索指南,对派安普利单抗在肝癌、鳞状非小细胞肺癌和鼻咽癌方面的拓展性应用予以推荐,对胃癌方面的应用不予推荐;通过可替代性评价对派安普利单抗头颈鳞癌、小细胞肺癌和胆管癌方面的拓展性应用进行推荐,对非鳞非小细胞肺癌方面的应用不予推荐。结论 建立了一种通过指南检索和同类竞品对比从而快速评价新型国产PD-1单抗拓展性应用的初步方案。

关键词: 派安普利单抗;国产PD-1单抗;拓展性应用;可替代性;快速评价

Abstract

Objective To analyze the expanded application of piamprilumab, establish a preliminary evalua- tion plan for the expanded application of a new domestic programmed death receptor-1 (PD-1) monoclonal anti- body, and provide basis and reference for clinical application.
Methods Collect drug information and evidence- based evidence of extended application to determine the scope of extended application; search relevant guidelines, and recommend extended applications that have been approved in foreign countries or have been recommended by guidelines; screened the approved indications or obtained For other similar drugs recommended by the guideline, recommendations for extended application are given through substitutable evaluation.
Results After preliminary screening, 8 expanded applications were identified; through the search guide, the expanded application of piam- prilumab in liver cancer, squamous non-small cell lung cancer and nasopharyngeal carcinoma was recommended, but not in gastric cancer. It is recommended; the expanded application of pianpilimumab in head and neck squamous cell carcinoma, small cell lung cancer, and cholangiocarcinoma is recommended through the evaluation of surrogacy, and the application in non-squamous non-small cell lung cancer is not recommended.
Conclusion   A preliminary scheme for rapid evaluation of the expandable application of the new domestic PD-1 mAb was established through the guideline search and comparison of similar competing products.

Key words: Pienpilimumab; Domestic PD-1 mAb; Expanded Application; Substitutability; Rapid Evaluation

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引用本文

王鹏翀, 朱亚宁, 史先鹏, 雍素云, 郝瑞芳, 张鹏, 新型国产PD-1单抗拓展性应用初步评价方案建立——以派安普利单抗为例[J]. 国际医药研究前沿, 2022; 6: (4) : 12-19.