Considerations on package inserts for chimeric antigen receptor T cells indicated for hematological malignancy
10.13699/j.cnki.1001-6821.2024.03.034
- VernacularTitle:嵌合抗原受体T细胞治疗血液系统肿瘤说明书撰写要求的探讨
- Author:
Chen-Yang ZHAO
1
;
Yun-Hong HUANG
;
Jing WANG
;
Shuang LU
Author Information
1. 国家药品监督管理局 药品审评中心,北京 100076
- Keywords:
chimeric antigen receptor T cell;
package insert;
clinical application
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(3):472-476
- CountryChina
- Language:Chinese
-
Abstract:
A number of chimeric antigen receptor T cells have been marketed in China,which bring new therapeutic options for patients with hematologic tumors.Compared with other drugs,the clinical application of such living cell products has certain special features.Package insert is the carrier of basic information,safety and effectiveness data of drugs,and is an important basis of rationally use for medical personnel and patients.In this paper,we mainly discuss the requirements for writing package inserts of chimeric antigen receptor T cells with cases,in order to provide reference for package inserts and improve the understanding in clinical application.
