CAR T-cell Therapy Articles | Page 3

FDA Grants BCMA CAR T-Cell Therapy Breakthrough Designation in Myeloma
The FDA has granted the the anti–B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy bb2121 a breakthrough therapy designation for previously treated patients with relapsed/refractory multiple myeloma.
CAR T-Cell Therapy Approval Starts New Path in Childhood Leukemia
Sarah K. Tasian, MD, discusses the success of CAR T-cell therapy, as well as novel agents and immunotherapies that appear promising in the treatment of children with leukemia.
Questions Remain With CAR-T's, Checkpoints in Hematologic Malignancies
Leo I. Gordon, MD, discusses promising advances and lingering challenges with novel treatments for patients with hematologic malignancies.
JCAR015 Experience Informs Future CAR-T Studies
The high rates of cerebral edema seen with JCAR015 in the phase II ROCKET trial were attributed to early and rapid chimeric antigen receptor (CAR)-modified T-cell expansion and a rise in interleukin-15 levels, a finding that could help inform future CAR T-cell usage.
Combinations Required to Further Advance Adoptive T-Cell Therapy
A variety of adoptive T-cell therapy strategies have shown promise in clinical studies with recent FDA approvals granted to CAR-modified T-cell therapies, representing the potential for future combination strategies.
FDA Lifts Holds on
The FDA today lifted clinical holds placed on 2 phase I trials investigating a gene-edited allogeneic CAR T-cell therapy known as UCART123.
Tisagenlecleucel Submitted for European Approval for ALL, DLBCL
The European Medicines Agency (EMA) has received a Marketing Authorization Application (MAA) for tisagenlecleucel (Kymriah) for 2 forms of advanced lymphoma.
Personalized Medicine Moving to Forefront of Hematologic Malignancies
Edward A. Stadtmauer, MD, sheds light on the future of chimeric antigen receptor T-cell therapy, systemic therapeutic advances in the field of acute myeloid leukemia, and remaining challenges in the multiple myeloma paradigm.
Novartis Submits sBLA for Tisagenlecleucel in Adults With Relapsed/Refractory DLBCL
Novartis has filed a supplemental biologics license application with the FDA to expand the indication for tisagenlecleucel (Kymriah) to include adults with relapsed/refractory DLBCL who are ineligible for ASCT.
DLBCL Landscape Shifts Dramatically With Axicabtagene Ciloleucel FDA Approval
Reem Karmali, MD, discusses ongoing key trials of CAR T-cell therapy, the chronic safety concerns with the treatment, and what combinations have the most potential.
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