CAR T-Cell Therapy Expanding: Early Data Shows Promising Results
- Expanding access to novel cancer treatments such as chimeric antigen receptor (CAR) T-cell therapy to more patients can happen onyl if the treatments can reach patients where they...
- More recently, CAR T-cell therapy has moved into newly authorized treatment centers (ATCs).
- !Olalekan Oluwole, MBBS, MD | Image: VUMC Olalekan Oluwole, MBBS, MD | Image: VUMC
Expanding access to novel cancer treatments such as chimeric antigen receptor (CAR) T-cell therapy to more patients can happen onyl if the treatments can reach patients where they are-and that means offering them not just in academic centers but also in community practices.
More recently, CAR T-cell therapy has moved into newly authorized treatment centers (ATCs). Data from a pair of abstracts presented during the recent American Society of Hematology Annual Meeting and Exposition in Orlando, Florida suggest thes newer ATCs are successfully delivering CAR T-cell therapy with outcomes on par with established academic centers.1,2
!Olalekan Oluwole, MBBS, MD | Image: VUMC
Olalekan Oluwole, MBBS, MD | Image: VUMC
Olalekan Oluwole, MBBS, MD, associate professor of medicine in hematology/oncology at Vanderbilt University Medical Center, spoke with the American Journal of Managed Care(AJMC) about his 2 abstracts, which examined real-world healthcare resource utilization and clinical outcomes at these newer centers.1,2
The Evolution of CAR T Access
When the first CAR T-cell therapies received FDA approval in 2017,3,4 Oluwole said they were rapidly adopted by major academic centers such as Vanderbilt, UCLA, the university of Pennsylvania, Moffitt Cancer Center, and The University of Texas MD Anderson Cancer Center. “They are the academic centers. They had all the expertise,FACT accreditation,3 and those were the centers that generated the early real-world data including many publications centered on how to improve the safety profile of this new therapy and how to carefully move them to the outpatient setting,” he said.
FACT accreditation refers to rigorous quality and safety standards set Foundation for the Accreditation of Cellular Therapy; this voluntary, peer-driven process can offer assurance to patients and physicians of high-quality care from cell collection to governance.5 FACT standards,
Abecma (ide-cel) for Large B-Cell Lymphoma
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Abecma (ide-cel), a CAR T-cell therapy, received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. FDA Approval Letter
How Abecma Works
Abecma is a chimeric antigen receptor (CAR) T-cell therapy. it involves collecting a patient’s T cells, genetically modifying them to express a CAR that targets the B-cell maturation antigen (BCMA) found on lymphoma cells, and then infusing the modified cells back into the patient to kill cancer cells. National Cancer Institute – CAR T-Cell Therapy
The process typically takes several weeks,including leukapheresis (collecting T cells),cell manufacturing,and conditioning chemotherapy before infusion. Patients require close monitoring for side effects, including cytokine release syndrome (CRS) and neurological toxicities.
FACT Accreditation and Cellular Therapy
foundation for the Accreditation of Cellular Therapy (FACT) accreditation signifies that a cellular therapy program, like those involved in producing CAR T-cell therapies such as Abecma, meets rigorous quality standards. As of January 12, 2026, FACT accreditation remains a crucial indicator of patient safety and treatment efficacy in the field of cellular therapy. FACT – What FACT Accreditation Means to Patients
what FACT Accreditation Means for Patients and Families
FACT accreditation ensures that cellular therapy programs adhere to specific standards for collecting, processing, and administering cells. This includes stringent quality control measures, personnel qualifications, facility standards, and data management practices.
Specifically, FACT accreditation covers aspects like cell collection and processing, quality control testing, patient selection, clinical management, and data reporting. Programs undergo a thorough on-site inspection to demonstrate compliance with these standards.
For example, FACT accreditation requires programs to have documented procedures for managing adverse events, such as cytokine release syndrome (CRS) and neurotoxicity, common side effects of CAR T-cell therapy. FACT Standards for Cellular Therapy Clinical Programs
- Bristol Myers Squibb: The manufacturer of Abecma. Bristol Myers Squibb
- U.S. Food and Drug Administration (FDA): The agency that approved Abecma. FDA
- Foundation for the Accreditation of Cellular Therapy (FACT): The accrediting body for cellular therapy programs. FACT
- National Cancer Institute (NCI): Provides information about CAR T-cell therapy. NCI