CAR T-Cell Therapy

Tisagenlecleucel was found to elicit clinically meaningful activity in patients with relapsed/refractory follicular lymphoma, meeting the phase 2 ELARA trial’s primary end point of complete response rate.

Paul J. Shaughnessy, MD, discusses challenges with CAR T-cell therapy in relapsed/refractory hematologic malignancies.

A biologics license application has been submitted to the FDA for idecabtagene vicleucel for the treatment of adult patients with relapsed and refractory multiple myeloma.

The FDA has approved the CAR T-cell therapy brexucabtagene autoleucel (Tecartus; formerly KTE-X19) as a treatment for adult patients with relapsed/refractory mantle cell lymphoma.

The FDA has cleared an investigational new drug application for the first-of-its-kind, off-the-shelf CAR T-cell product FT819, which targets CD19-positive malignancies.

Paul J. Shaughnessy, MD, discusses the available CAR T-cell therapies for relapsed/refractory hematologic malignancies.

The European Medicines Agency has validated a Marketing Authorization Application for the CD19-directed CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and grade 3B follicular lymphoma following at least 2 prior therapies.

Advances of chimeric antigen receptor T-cell therapy technologies are in rapid development and under investigation in a range of preclinical and clinical research around the globe.

The FDA has issued a clinical hold on the phase 1 MELANI-01 trial evaluating the CAR T-cell product UCARTCS1A in the treatment of patient with relapsed/refractory multiple myeloma.

Nikhil C. Munshi, MD, discusses the next steps for research with idecabtagene vicleucel in relapsed/refractory multiple myeloma.