FACT Standards require reporting of adverse events related to cellular therapy product administration. FACT does not dictate the process or timing of such reporting, but requires that the reporting meets the requirements of applicable laws and regulations. We have fielded many questions via workshops, emails, and telephone calls regarding the reporting of adverse events related to commercial cellular therapy products (e.g., Kymriah, Yescarta).
Many stakeholders in the field are working on initiatives to make data reporting, including adverse event reporting, a more streamlined process. In the meantime, the FACT Immune Effector Cell Task Force recommends that programs define a reporting process and document it in a Standard Operating Procedure (SOP). The following are some tips for creating the process:
- Know, understand, and comply with the reporting requirements outlined in the Risk Evaluation and Mitigation Strategies (REMS) for the specific product(s) you administer. List these requirements in the SOP.
- For remaining gaps in the process, define your program’s reporting elements and frequency of reporting, including:
- The types of adverse events that your program will report immediately (e.g., all events, specific grades of cytokine release syndrome) and to what source (e.g., MedWatch, manufacturer).
- The types of adverse events that your program will collate for future reporting, the frequency of reporting such adverse events, and to whom the information will be reported.
- Maintain documentation of all adverse events and reporting records.
- Develop an audit plan and schedule for monitoring compliance with REMS requirements and the program-defined process.
- Regularly check in with your manufacturer contacts for any updates to their adverse event reporting requirements.
For additional information regarding adverse event reporting, visit the REMS websites of Kymriah and Yescarta, review FDA requirements for manufacturer reporting in 21 CFR 600.80 Postmarketing reporting of adverse experiences, and Standard B4.10 and its substandards in the FACT-JACIE HCT Standards and the FACT IEC Standards.