CAR T-cell Therapy

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.

The FDA has approved ide-cel (Abecma) for adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy.

CTL019 CAR T-cell therapy plus time-limited ibrutinib resulted in high complete response rates in relapsed/refractory mantle cell lymphoma.

Saad J. Kenderian, MB, CHB, expands on the significance of liso-cel’s approval in chronic lymphocytic leukemia or small lymphocytic lymphoma.

The European Commission has approved idecabtagene vicleucel for triple-class–exposed relapsed/refractory multiple myeloma.

Treatment with a next-generation CAR T-cell agent displayed early efficacy in a small group of patients with glioblastoma.

The FDA’s Oncologic Drugs Advisory Committee voted in favor of idecabtagene vicleucel for patients with early relapsed/refractory myeloma.

The FDA’s Oncologic Drugs Advisory Committee voted in favor of ciltacabtagene autoleucel for patients with early relapsed/refractory myeloma.

The FDA has granted accelerated approval to lisocabtagene maraleucel for the treatment of select patients with relapsed/refractory CLL or SLL.

A CAR T-cell therapy directed toward 2 brain tumor–associated proteins displayed preliminary activity in recurrent glioblastoma.

David L. Porter, MD, discusses the decision by the FDA to call for a boxed warning for secondary malignancies on all approved CAR T-cell agents.

Rahul Banerjee, MD FACP, discusses the FDA’s decision to add a class-wide boxed warning for secondary malignancies on all approved CAR T-cell therapies.

China’s NMPA has approved zevor-cel for the treatment of adult patients with relapsed/refractory multiple myeloma after at least 3 lines of therapy.

Andre H. Goy, MD, discusses how the ZUMA-18 trial data support the benefit of earlier-line use of brexucabtagene autoleucel in mantle cell lymphoma.

Tatyana Feldman, MD, highlights updated data for liso-cel in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.

Sagar Lonial, MD, FACP, details how CAR T-cell therapies and off-the-shelf treatments are improving outcomes for patients with multiple myeloma.

The FDA has called to add a class-wide boxed warning for CAR T-cell therapies to alert patients of the risk of developing secondary T-cell malignancies.

The FDA has accepted for review the BLA for obecabtagene autoleucel's use in patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

Maurie Markman, MD, discusses current challenges faced with developing robust decision support tools for oncologists and projects additional research efforts dedicated to finding a way to leverage CAR T-cell therapies in solid tumors to improve patient outcomes.

Maurie Markman, MD, highlights inroads made with immunotherapy, antibody-dependent cytotoxic agents, and molecular testing across oncology.

The FDA has approved label updates for zanubrutinib to include data from the ALPINE trial in relapsed/refractory chronic lymphocytic leukemia, and axicabtagene ciloleucel to include findings from the primary overall survival analysis of the ZUMA-7 trial in relapsed/refractory large B-cell lymphoma.

Patients with relapsed/refractory follicular lymphoma experienced durable responses when treated with tisagenlecleucel (Kymriah) in the phase 2 ELARA study (NCT03568461), according to data presented at the 2023 ASH Annual Meeting.

The administration of axicabtagene ciloleucel in the second-line setting improved overall survival and progression-free survival vs standard-of-care treatment in patients with relapsed/refractory large B-cell lymphoma who are at least 65 years of age.

The utilization of remote patient monitoring within the first 30 days of outpatient CAR T-cell therapy can promote patient safety, reduce costs, and decrease hospitalization rates by allowing patients with hematologic malignancies to connect with a virtual care platform.

Idecabtagene vicleucel resulted in meaningful improvements in symptoms, functioning, overall health status, and health-related quality of life vs standard regimens in select patients with triple-class exposed relapsed/refractory multiple myeloma, according to updated data from the phase 3 KarMMa-3 trial.

Shortages of several anticancer drugs continue to negatively impact clinicians’ ability to deliver the best possible care to patients.