Updated August 2026
Chimeric Antigen Receptor T-cell (CAR-T) therapy continues to revolutionize cancer treatment, offering new hope for patients with difficult-to-treat hematologic malignancies. As of 2025, seven FDA-approved CAR-T therapies are available, each targeting specific cancers such as acute lymphoblastic leukemia (ALL), large B-cell lymphoma, and multiple myeloma.
These groundbreaking treatments, developed by leading pharmaceutical companies like Novartis, Kite, and Gilead, highlight advancements in personalized medicine. With new approvals expanding the scope of treatment options, CAR-T therapy remains at the forefront of innovative cancer care, offering patients tailored solutions based on their unique medical needs.
As of January 2025, the U.S. Food and Drug Administration (FDA) has approved the following chimeric antigen receptor T-cell (CAR-T) therapies:
- Kymriah™ (tisagenlecleucel): Approved for pediatric and young adult patients (up to 25 years) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), and for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
- Yescarta™ (axicabtagene ciloleucel): Indicated for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
- Tecartus™ (brexucabtagene autoleucel): Approved for adult patients with relapsed or refractory mantle cell lymphoma, and for adult patients with relapsed or refractory B-cell precursor ALL.
- Breyanzi™ (lisocabtagene maraleucel): Indicated for certain adults with relapsed or refractory large B-cell lymphoma, including DLBCL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. It is also approved for eligible adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma. Eligibility and required previous treatments vary by disease.
- Abecma™ (idecabtagene vicleucel): Approved for adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
- Carvykti™ (ciltacabtagene autoleucel): Indicated for adult patients with relapsed or refractory multiple myeloma after at least one or more prior lines of therapy.
- Aucatzyl™ (obecabtagene autoleucel): Recently approved in November 2024, this therapy is indicated for adult patients with relapsed or refractory B-cell precursor ALL.
CAR-T Updates for 2026: What Has Changed?
Since this article was first published, several important regulatory changes and expanded indications have increased the number of patients who may be considered for FDA-approved CAR-T therapy.
CAR-T Approved for Marginal Zone Lymphoma
In December 2025, the FDA expanded the indication for Breyanzi to include adults with relapsed or refractory marginal zone lymphoma who had received at least two previous lines of systemic therapy. This was the first CAR-T therapy approved in the United States for marginal zone lymphoma.
Breyanzi now has FDA-approved indications covering several B-cell malignancies, including large B-cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma.
CAR-T Is Being Used Earlier in Multiple Myeloma
FDA-approved CAR-T therapy for multiple myeloma is no longer restricted only to patients who have received four or more previous lines of treatment.
Carvykti may be used in certain adults after at least one previous line of therapy, while Abecma may be considered after at least two previous lines. The exact eligibility requirements depend on the treatments previously received, the patient’s response, and the characteristics of the disease.
This change allows some patients to be evaluated for CAR-T earlier in the course of multiple myeloma.
FDA Removed the CAR-T REMS Requirements
In June 2025, the FDA eliminated the Risk Evaluation and Mitigation Strategies, or REMS, requirements for approved autologous CD19- and BCMA-directed CAR-T therapies.
The change reduced some of the administrative requirements surrounding treatment delivery. However, CAR-T remains an intensive treatment that requires careful patient selection, monitoring, and management of possible complications, including cytokine release syndrome and neurological toxicity.
FDA-Approved CAR-T Versus Point-of-Care CAR-T
FDA-approved CAR-T products are commercial therapies manufactured at centralized production facilities. However, this is not the only CAR-T manufacturing model.
Some hospitals in Israel offer point-of-care CAR-T programs in which the patient’s cells are processed locally rather than sent to an overseas commercial manufacturing facility. This approach may reduce manufacturing time and treatment costs.
Point-of-care CAR-T therapies should not be described as FDA-approved products. They are hospital-based treatment programs operating under the relevant Israeli medical and regulatory framework. Every application is reviewed individually by the treating medical team.
International patients with multiple myeloma, lymphoma, or leukemia may submit their medical records for an initial assessment to determine whether an available CAR-T program could be relevant to their case.
Recent Advancements and Ongoing Research 2025
- Solid Tumor Applications: Researchers are making progress in extending CAR-T therapy to solid tumors, focusing on antigen identification and structural innovations to overcome challenges like antigen heterogeneity and immunosuppressive tumor microenvironments.
- Off-the-Shelf CAR-T: A pivotal phase 2 trial of WU-CART-007, an anti-CD7 CAR-T therapy for relapsed/refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma, is set to begin in early 2025.
- Autoimmune Disease Applications: CAR-T therapy is being explored for autoimmune conditions such as lupus and multiple sclerosis, with several companies conducting phase 2 trials.
- Organ Transplantation: Mayo Clinic researchers are investigating the use of CAR-T cells to prevent organ rejection in sensitized patients, potentially revolutionizing kidney transplants.
- Manufacturing Innovations: Novel approaches like the Sleeping Beauty transposon system, mRNA-based CAR transfection, and in vivo CAR-T cell production are being developed to improve accessibility and scalability.
- Enhanced Safety and Efficacy: Strategies to mitigate side effects like cytokine release syndrome (CRS) and improve CAR-T cell persistence are being developed, including CRISPR-Cas9 modifications and combination therapies with checkpoint inhibitors. These advancements demonstrate the rapidly evolving landscape of CAR-T cell therapy, with ongoing efforts to expand its applications beyond hematological malignancies and improve overall efficacy and safety profiles.
Sources:
FDA-approved cellular and gene therapy products
FDA approval of Breyanzi for marginal zone lymphoma
FDA removal of CAR-T REMS requirements
www.aabb.org
www.frontiersin.org
https://cancerblog.mayoclinic.org/
www.targetedonc.com
www.aacr.org/
https://pubmed
https://www.cancernetwork.com/
Our team attended the 7th European CAR T-cell Meeting (CART25) in Strasbourg, France, to gain first-hand insights into the latest advancements in CAR-T cell therapy.
