CAR T-Cell Therapy

This list features a snapshot of key August FDA oncology decisions, efforts to integrate health equity into guideline development, and more.

Tisagenlecleucel is moving to earlier lines of therapy for pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Here is your snapshot of all therapeutic options that the FDA approved in August 2024 and their clinical implications.

The FDA has granted fast track designation to the allogeneic CAR T-cell therapy CB-012 for relapsed/refractory acute myeloid leukemia.

Marco Davila, MD, PhD, discusses how to shape the future of medicine with gene and cell therapy.

The EMA has expanded the indication for lisocabtagene maraleucel to include the treatment of patients with relapsed or refractory follicular lymphoma.

The FDA has granted fast track designation to Deltacel in combination with low-dose radiation for pretreated metastatic non–small cell lung cancer.

The FDA cleared the SeCore CDx HLA A Sequencing System as a companion diagnostic for afamitresgene autoleucel in advanced synovial sarcoma.

Alemtuzumab was FDA granted orphan drug designation as part of lymphodepletion prior to UCART22 in relapsed/refractory B-cell acute lymphoblastic leukemia.

The FDA has granted accelerated approval to afamitresgene autoleucel for select patients with pretreated unresectable or metastatic synovial sarcoma.

The incidence of ICANS and CRS post-CAR T-cell therapy decreased after 2 weeks in patients with DLBCL, supporting a reduction of the monitoring period.

Francisco Hernandez-Ilizaliturri, MD, details factors that influence CAR T-cell therapy selection in relapsed/refractory follicular lymphoma.

GLPG5101 produced high CRs in patients with relapsed/refractory non-Hodgkin lymphoma, indicating the feasibility of decentralized CAR T manufacturing.

Cilta-cel improved overall survival vs standard regimens in relapsed/lenalidomide-refractory multiple myeloma after 1 prior line of therapy.

Rahul Banerjee, MD, FACP, of Fred Hutchinson Cancer Center, discusses strategies to improve the benefits of CAR T-cell therapy in multiple myeloma.

Armored huCART19-IL18 treatment was tolerable in patients with relapsed/refractory lymphomas who progressed after CD19-directed 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.

Sattva S. Neelapu, MD, discusses processes that have been adopted to streamline the delivery of CAR T-cell therapy to patients with lymphoma.

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