CAR T-cell Therapy

The FDA has modified the risk evaluation and mitigation strategies for CAR T-cell therapies approved for hematologic malignancies.

Liso-cel continued to show improved disease control and EFS and PFS vs SOC in the second-line treatment of patients with large B-cell lymphoma.

MB-106 showcased a favorable safety profile and elicited responses in heavily pretreated patients with refractory Waldenström macroglobulinemia.

Minoo Battiwalla, MD, discusses the role of bispecific antibodies as an alternative to CAR T-cell therapies in NHL, treatment strategies for aggressive follicular lymphomas, and more.

The CD7-targeted CAR T-cell therapy WU-CART-007 had a manageable safety profile and elicited preliminary efficacy signals in relapsed/refractory T-ALL/LBL.

Marie Hu, MD, discusses considerations for the use of CAR T-cell therapy and bispecific antibodies in relapsed/refractory diffuse large B-cell lymphoma.

Minoo Battiwalla, MD, MS, discusses the impact of earlier-line FDA approvals for CAR T-cell therapies on treatment outcomes in multiple myeloma.

Axi-cel administration was safe and clinically active in relapsed/refractory primary and secondary central nervous system lymphoma.

David A. Braun, MD, PhD, highlights the developing role of T-cell therapies in RCC and looks toward the horizon for other advances.

The European Commission granted orphan drug designation to UCART22 for acute lymphoblastic leukemia.

Here is your guide to important regulatory approvals made by the FDA in May 2024.

The FDA approved liso-cel for the treatment of adult patients with relapsed/refractory mantle cell lymphoma after at least 2 prior lines of therapy, including a BTK inhibitor.

CT041 was safe and showcased early signals of antitumor activity in heavily pretreated patients with metastatic pancreatic cancer.

James Ignatz-Hoover, MD, PhD, discusses the evolving use of CAR T-cell therapies and bispecific antibodies in multiple myeloma.

Carrie L. Kitko, MD, discusses the current standing of cellular therapies in adult and pediatric ALL and looks toward future developments.

Sattva S. Neelapu, MD, discusses the optimal processes of CAR T-cell therapy administration and the remaining unmet needs in the space.

WU-CART-007 has received RMAT and PRIME designations in relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.

Sattva S. Neelapu, MD, discusses the current standing of CAR T-cell therapies in the treatment paradigm in lymphoma.

The FDA has granted accelerated approval to lisocabtagene maraleucel for the treatment of select adult patients with relapsed or refractory follicular lymphoma.

CAR T-cell therapy is effective and tolerable in patients with mantle cell lymphoma with secondary central nervous system involvement.

Samer A. Srour, MB ChB, MS, explains the significance of early safety and efficacy data with CTX130 in CD70-expressing clear cell renal cell carcinoma.

Kenneth C. Anderson, MD, discusses the recent ODAC decisions for ide-cel and cilta-cel, highlighting clinical trial data supporting the indications.

Sequential CD7 CAR T-cell therapy plus haploidentical HSCT without GVHD prophylaxis is effective and safe in CD7-positive hematologic malignancies.

Cilta-cel has received approval from the European Commission for multiple myeloma that is relapsed or refractory to at least 1 prior line of therapy.

Saad Z. Usmani, MD, MBA, FACP, FASCO, discusses the significance of the FDA approval of cilta-cel in relapsed/refractory multiple myeloma.

The FDA has mandated that the boxed warning for all approved CAR T-cell therapies be updated to include the serious risk of T-cell malignancies.

Experts discuss the FDA's call for a boxed warning for secondary T-cell malignancies on all approved CAR T-cell agents in late January 2024.

Simulation-based education can improve health care professionals’ understanding and confidence regarding the treatment of patients with CAR T-cell therapy.

In case you missed it, these were the key regulatory decisions made by the FDA in March 2024.

The FDA has approved cilta-cel for select patients with relapsed/refractory multiple myeloma who have received at least 1 line of therapy, and who are lenalidomide refractory.