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Rahul Banerjee/fredhutch.org

Jun 30, 2025, 08:58

Rahul Banerjee: Excellent News – FDA Eliminates REMS Across CAR-T Products for US Patients

Rahul Banerjee, Assistant Professor at Fred Hutchinson Cancer Center at the University of Washington, shared a post on X:

“Excellent news for US patients receiving CAR-T therapy!

FDA has listened to data and relaxed CRS monitoring and driving restrictions for liso-cel for lym/ide-cel for MM.

Huge step to lower time toxicity and disparities.

Can this be fixed for all CAR-T products?

Rahul Banerjee: Excellent News - FDA Eliminates REMS Across CAR-T Products for US Patients

Heard through Mazyar Shadman.

Link to company announcement.

And our Blood Advances work from the US MM consortium demonstrates low utility to 8-week driving restrictions with CAR-T for myeloma, including ide-cel (fixed) and cilta-cel (not quite yet). Others have investigated 2-week CRS monitoring as well.

Update – FDA announcement now out, and sorry I spoke too soon!

REMS are now eliminated entirely across products: this is excellent news for patients. Our CAR-T programs have the expertise needed to personalize safety monitoring.

Thanks to advocacy by ASTCT and many others.”

Quoting Bruce Levine, Professor at Penn Medicine, post:

“Big News for CAR T cell delivery to patients and monitoring: FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies.”

Read further.

Title: Universal driving restrictions beyond 4 weeks appear unnecessary following CAR-T therapy in multiple myeloma

Authors: Rahul Banerjee, Alicia Richards, Shonali Midha, Aimaz Afrough, Faiz Anwer, Djordje Atanackovic, Shebli Atrash, Veronika Bachanova, Amer M. Beitinjaneh, Evguenia Bhurtel, Omar Castaneda Puglianini, Saurabh Chhabra, Kara I. Cicero, James A. Davis, Binod Dhakal, Danai Dima, Christopher J. Ferreri, Peter A. Forsberg, Ciara L. Freeman, Megan M. Herr, Tania Jain, Murali Janakiram, Jack Khouri, Mehmet H. Kocoglu, Anupama Kumar, Yuxin Liu, Frederick Locke, Joseph P. McGuirk, Lekha Mikkilineni, Omar Nadeem, Ricardo D. Parrondo, Oren Pasvolsky, Lauren C. Peres, Sneha Purvey, Shahzad Raza, Ran Reshef, Shambavi Richard, Adriana C. Rossi, Douglas W. Sborov, Leyla Shune, Charlotte B. Wagner, Saurabh S. Zanwar, Surbhi Sidana, Krina K. Patel, Doris K. Hansen, Shaji K. Kumar, Yi Lin, Thomas G. Martin, Peter M. Voorhees, Larry D. Anderson, Jr, Andrew J. Cowan, Gurbakhash Kaur

Rahul Banerjee: Excellent News - FDA Eliminates REMS Across CAR-T Products for US Patients