Perspective: An International Fludarabine Shortage: Supply Chain Issues Impacting Transplantation and Immune Effector Cell Therapy Delivery
Richard T. Maziarz, Amber Diaz, David B. Miklos, Nirav N. Shah
Abstract
Host immune depletion has been recognized as a necessary step for successful adoptive immune cell transfer in both the autologous and allogeneic settings. The chemotherapy agent fludarabine as an immune suppressive agent has a central role in multiple conditioning regimens for both transplantation and immune effector cell therapies. With the recent and sudden recognition of an imminent worldwide fludarabine shortage, novel approaches to overcome supply chain disruption are needed, including exploration of alternative therapies. The fludarabine shortage has highlighted the need to prioritize the development of institutional algorithms for maintaining ongoing clinical trials and standard of care procedures in the setting of critical drug shortages.