CAR T-cell Therapy | Specialty

Rolling Submission to FDA Completed for Cilta-Cel for Relapsed/Refractory Multiple Myeloma

April 6th 2021

The rolling submission of a biologics license application to support the approval of the investigational BCMA-directed CAR T-cell therapy ciltacabtagene autoleucel for the treatment of patients with relapsed/refractory multiple myeloma has been completed.

FDA Approval Sought for Brexucabtagene Autoleucel for Relapsed/Refractory B-Cell ALL

April 2nd 2021

A supplement biologics license application has been submitted to the FDA for brexucabtagene autoleucel as a treatment for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

Third-Line CAR T-Cell Therapy Improves Outcomes in B-Cell Lymphomas

April 1st 2021

CAR T-cell therapies are now incorporated into National Comprehensive Cancer Network guidelines as a recommended third-line strategy in this setting, with the most recent addition being lisocabtagene maraleucel.

Canadian Collaborative Launches to Provide Infrastructure for Cancer Cell Therapy Research

March 31st 2021

The Canada Foundation for Innovation has awarded C$5,187,685 to the Canadian Cancer Trials Group at Queen’s University in Kingston, Ontario, Canada, to fund the infrastructure for a new research platform to coordinate the development of new cancer cell therapies.

Liso-Cel Approved in Japan for Relapsed/Refractory Large B-Cell Lymphoma

March 29th 2021

Japan’s Ministry of Health, Labour and Welfare has approved lisocabtagene maraleucel, a CAR T-cell therapy designed to target CD19, for the treatment of patients with relapsed or refractory large B-cell lymphoma, as well as relapsed/refractory follicular lymphoma.

FDA Approves Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma

March 27th 2021

The FDA has approved idecabtagene vicleucel as the first BCMA-directed CAR T-cell therapy for patients with relapsed/refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Liso-Cel Shows Encouraging Clinical Activity, Safety in Relapsed/Refractory MCL

March 19th 2021

M Lia Palomba, MD, discusses the data from the TRANSCEND-NHL-001 trial and projected how lisocabtagene maraleucel could fit into the treatment paradigm for patients with MCL.

New Approvals and Real-World Data Complicate Treatment Selection in Large B-Cell Lymphoma

March 18th 2021

Matthew Lunning, DO, discusses the findings from pivotal CAR T-cell therapy trials in LBCL, the potential to utilize these agents in the outpatient setting, how off-the-shelf allogeneic products could further transform outcomes, and the importance of shortening brain-to-vein time for this patient population.

Real-World Data Showcase Favorable Outcomes and Less Toxicity With Axi-Cel in Large B-Cell Lymphoma

March 17th 2021

The real-world utilization of axicabtagene ciloleucel demonstrated favorable outcomes and less frequent toxicity events compared with those reported in the pivotal ZUMA-1 trial and other real-world studies.

Frontline Axi-Cel Elicits 74% CR Rate in High-Risk Large B-Cell Lymphoma

March 15th 2021

Axicabtagene ciloleucel elicited a high objective response rate of 85%, with a complete response rate of 74% when used as a first-line therapy in patients with high-risk large B-cell lymphoma.

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