M. Bilal Abid: From Risk to Reach – How REMS Remediation Will SAhape CR-T Access
M. Bilal Abid, Clinical Fellow, Hematology/Oncology at The University of Texas Health Science Center at Houston, shared a post on LinkedIn:
“From Risk to Reach: How REMS Remediation Will Shape CAR-T Access
Main points from our publication below:
The REMS program was established under the FDA Amendments Act of 2007, which amended the Food, Drug, and Cosmetic Act to include Section 505-1. This legislation authorized the FDA to mandate REMS for drugs with serious safety concerns to ensure safe use while maintaining efficacy and access to patients.
- The REMS for the first CAR-T product was developed in 2017 during the FDA review and mandated treatment centers to have specialized training, intensive care unit access, and tocilizumab availability.
- Over time, the CAR-T community recognized several key insights that reshaped perspectives on the REMS safety monitoring program. The main one was access disparities impacting survival.
- The FDA’s decision on June 26, 2025, to eliminate the REMS requirements for all approved BCMA- and CD19-directed autologous CAR-T therapies is timely and very welcome! (Changes summarized in my previous post)
- In our view (personal opinion), the end of REMS is more than just a regulatory change—it is a catalyst for democratizing access, reducing delivery costs and patient burden, academic-community-industry collaboration, and innovation across the CAR-T ecosystem.
- Humbled that we were able to contribute towards this a little over time. Kudos to my co-author, Nausheen Ahmed, M.D. , whose research work over the years also contributed to this change!
Looking forward to your thoughts on this decision. Link to the publication.
Thanks for your advocacy: ASTCT CIBMTR (Center for International Blood & Marrow Transplant Research), NMDP, American Society of Hematology, The Leukemia & Lymphoma Society FDA.”
Title: From Risk to Reach: How REMS Remediation Will Shape CAR-T Access
Authors: Muhammad Abid, Noufil Adnan, Nausheen Ahmed
You can read the Full Article in Transplantation and Cellular Therapy.
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