Tanja Obradovic: The spotlight of FDA last week
Tanja Obradovic, Vice President of Oncology Scientific Affairs at
“Approved autologous CAR-T cell immunotherapies were in the spotlight of FDA last week. For BCMA– or CD19-directed chimeric antigen receptor T-cell therapies, the FDA announced it now requires a boxed warning. The warning to highlight the serious risk of T cell malignancies is based on investigations that started in November 2023, as well as issued label changes for all 6 relevant products made in January 2024. Based on an evaluation of data from postmarketing adverse event and clinical trial reports, FDA stated that mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. How this risk affects use of these products remains to be seen by oncology community in the future.”