On May 17, 2022, China Center for Drug Evaluation (CDE) released the Technical Guidelines on the Evaluation of Immune-related Adverse Events (irADR) in Immuno-oncology (hereafter referred to as Guidelines) with immediate effect.
The Guidelines applies to immuno-oncology, also known as cancer immunotherapy. It proposes the definition of irAE as all levels of adverse drug reactions (ADR) that are confirmed to have causal connections with the immune mechanism. The relationship between irAE, ADR, treatment emergent adverse event (TEAE), and adverse events (AE) is as follows1:
The relationship between irAE, ADR, treatment emergent adverse event (TEAE), and adverse events (AE)
Besides putting forward a definition of irAE, the Guidelines also specifies
the factors and procedures for confirming irAE;
requirements for compiling irAE information in medication package inserts.
By setting up a unified definition, standards, and requirements for irAE, the Guidelines aims to
help researchers identify and confirm irAE in clinical trials in a more scientific and sound way;
improve the quality of investigator's brochure (IB), clinical study report (CSR), summary of clinical safety (SDS), and the medication package inserts.
better protect clinical trial subjects and the patients who use the drug in the post-marketing stage.
At the same time, since immuno-oncology drug is relatively new compared to traditional cytotoxic drugs and small-molecule targeted drugs, CDE says the Guidelines on irAE of immune-oncology drugs will be updated and improved.
CDE also advise researchers and sponsors to refer to other relevant regulations—Good Clinical Practices (GCP), ICH guidelines, and CDE guidelines such as Guidelines for Collecting Adverse Drug Reaction Data for Anticancer Drugs' Medication Package Inserts.
For any interest in the irAE Guidelines, welcome to contact BaiPharm for further details.
