People’s Daily Online, Beijing, May 19 (Reporter Sun Hongli) Tumor immunotherapy is a hot spot in the current research and development of new anti-tumor drugs. How to improve the scientificity and robustness of the identification and determination of immune-related adverse events, improve the quality of instruction manual writing, and effectively guarantee The safety of patients’ medication is an urgent problem that regulators and the industry need to solve.
According to the official website of the State Food and Drug Administration, recently, the Center for Drug Evaluation of the State Food and Drug Administration issued the “Technical Guidelines for the Evaluation of Immune-related Adverse Events in Anti-tumor Therapy”, which is the first anti-tumor therapy in my country. The technical guidelines for the identification and determination of immune-related adverse events, with the goal of improving the quality of safety reports and instructions, and strengthening the protection of subjects participating in clinical trials and patients receiving post-marketing medication.
This technical guideline points out that there is currently no relevant technical guideline for the identification and determination of immune-related adverse events (irAEs), resulting in different irAE definitions and determination processes in different drug clinical trials. , it is difficult to comprehensively and systematically identify and analyze irAEs when summarizing safety data, which will not be conducive to the full presentation of the safety information of the instructions, and may affect the medication safety of patients.
This technical guideline is applicable to tumor immunotherapy. According to the mechanism of action of immunotherapy drugs and the characteristics of irAEs, scientific suggestions are put forward on the definition and determination process of irAEs, the data presentation forms of irAEs in clinical trials of different research designs are clarified, and the consideration of the relevant adverse reaction information in the instructions is clarified.