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FDA Approval Sought for Axicabtagene Ciloleucel in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
A supplemental biologics license application has been filed with the FDA for axicabtagene ciloleucel for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma following 2 or more previous lines of systemic therapy.

Nina Shah, MD, discusses the phase 1/2 EVOLVE study with orvacabtagene autoleucel in relapsed/refractory multiple myeloma.

Pashna N. Munshi, MD, discusses the CAR T-cell therapies that have emerged in the lymphoma space and highlights the next steps for research with these products.

Luciano J. Costa, MD, discusses the emerging role of CAR T-cell therapy in relapsed/refractory multiple myeloma, investigational products such as ide-cel, orva-cel, and JNJ-4528, and early intervention strategies to manage the toxicities associated with these products.

The FDA has placed a clinical hold on the phase 1 P-PSMA-101-001 trial examining the autologous CAR T-cell therapy P-PSMA-101 in patients with metastatic castration-resistant prostate cancer.

Sattva Neelapu, MD, discussed findings from the first-in-human phase 1 ALPHA study which demonstrated encouraging short-term efficacy, along with manageable toxicities, with ALLO-501 and ALLO-647.

Nina Shah MD, discusses the future of CAR T-cell therapy and bispecific antibodies in multiple myeloma.

Nina Shah, MD, discusses ongoing research with BCMA-directed CAR T-cell therapy in relapsed/refractory multiple myeloma.

Nina Shah, MD, discusses the updated efficacy findings of JNJ-4528 from the phase 1b/2 CARTITUDE-1 study in relapsed/refractory multiple myeloma.

Nina Shah, MD, discusses the future of CAR T-cell therapy in multiple myeloma.

Jae Park, MD, discusses the benefits of off-the-shelf CAR T-cell therapy in acute lymphoblastic leukemia.

Jae Park, MD, discusses considerations for CAR T-cell therapy in relapsed/refractory acute lymphoblastic leukemia.

Muhammad Bilal Abid, MD, MRCP, discusses challenges with CAR-T cell therapy during the coronavirus disease 2019 pandemic.

A CD30-targeted CAR T-cell therapy was found to elicit a high rate of durable complete responses (CRs) in heavily pretreated patients with relapsed/refractory Hodgkin lymphoma.

Paul J. Shaughnessy, MD, discusses the challenges faced with CAR T-cell therapy in hematologic malignancies.

Paul J. Shaughnessy, MD, discusses how CAR T-cell therapy is being utilized in hematologic malignancies, challenges faced with this modality, and ongoing research efforts being made to better leverage its use.

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.































































