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Navneet Majhail: 80/20 effort to reduce REMS burden for Cell Therapy treatment centers

Navneet Majhail/X

Mar 4, 2025, 11:50

Navneet Majhail: 80/20 effort to reduce REMS burden for Cell Therapy treatment centers

Navneet Majhail, Physician-in-Chief of Blood Cancers at Sarah Cannon, shared a paper Frederick L. Locke and colleagues authored on LinkedIn:

“Kudos to the work by ASTCT 80/20 effort to reduce REMS burden for Cell Therapy treatment centers.

Highlights include:

– Significant collaborative efforts have led the FDA to curtail CAR-T REMS programs.

– Society guidelines and center practices should replace prior REMS requirements.

– Aggregating standardized data in a single repository tracks safety more effectively.

– Accrediting bodies may allow manufacturers to relinquish some oversight tasks.

– Inexperienced centers and emerging toxicities require nimble oversight approaches.

Appreciate the leadership of Frederick Locke, Sarah Nikiforow, Miguel-Angel Perales, Krishna Komanduri, Matthew Frigault, Partow Kebriaei, Zahra Mahmoudjafari, and many others who participated in this multi stakeholder initiative.”

Awakening from REMS: ASTCT 80/20 Ongoing Recommendations for Safe Use of Chimeric Antigen Receptor T Cells

Authors: Frederick L. Locke et al.

Navneet Majhail

cancer Frederick L. Locke Krishna V. Komanduri Matthew J. Frigault Miguel-Angel Perales Navneet Majhail Noelle Frey OncoDaily Oncology Partow Kebriaei Rebecca A. Gardner Sarah Nikiforow Zahra Mahmoudjafari

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