Non-Hodgkin Lymphoma

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.

Itacitinib prophylaxis showed signals for reducing CRS and ICANS following treatment with axicabtagene ciloleucel in patients with B-cell lymphoma.

Nanatinostat plus valganciclovir generated antitumor activity in patients with EBV-positive PTCL in the NAVAL-1 trial.

Glofitamab plus chemotherapy generated an overall survival improvement vs rituximab plus chemotherapy in relapsed/refractory diffuse large B-cell lymphoma.

In case you missed it, these were the key regulatory decisions made by the FDA in March 2024.

The novel CAR T-cell agent HR001 was effective, with durable responses and a favorable safety profile observed, in relapsed/refractory non-Hodgkin lymphoma.

The FDA issued complete response letters to the BLA for odronextamab in relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.

The FDA has accepted the resubmission of the BLA seeking the approval of denileukin diftitox-cxdl for relapsed/refractory cutaneous T-cell lymphoma.

Brentuximab vedotin/lenalidomide/rituximab led to an OS improvement vs lenalidomide/rituximab/placebo in relapsed/refractory diffuse large B-cell lymphoma.

The FDA has lifted a partial clinical hold on a phase 1 trial evaluating NX-2127 in relapsed/refractory B-cell malignancies

The FDA granted accelerated approval to zanubrutinib in combination with obinutuzumab for select patients with relapsed/refractory follicular lymphoma.

Muhamad Alhaj Moustafa, MD, MS, discusses the evolution of bispecific antibodies in diffuse large B-cell lymphoma.

Rahul Banerjee, MD, FACP, discusses the use of nivolumab in multiple myeloma or non-Hodgkin lymphoma after progression following CAR T-cell therapy.

Early data seen with acalabrutinib plus axi-cel indicate the combination’s feasibility as bridging therapy in relapsed/refractory B-cell lymphoma.

Brexu-cel showed efficacy in eliciting both CNS and systemic responses in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Catherine C. Coombs, MD, spotlights the use of bispecific antibodies in diffuse large B-cell lymphoma and pirtobrutinib in mantle cell lymphoma.

Julie M. Vose, MD, MBA, discusses the mitigation of toxicities with epcoritamab in an optimization cohort of patients with relapsed/refractory DLBCL.

BRL-201 had a manageable safety profile and elicited early indications of efficacy in patients with relapsed/refractory non-Hodgkin lymphoma.

Sikander Ailawadhi, MD, discusses characteristics of myelofibrosis that influence decisions between JAK inhibitors, highlights differences between bispecific antibodies to consider when managing diffuse large B-cell lymphoma, and more.

Lori A. Leslie, MD, discusses the efficacy and safety of second-line axicabtagene ciloleucel in elderly patients with high-risk, relapsed/refractory large B-cell lymphoma.

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.

Drs Lunning and Mehta-Shah highlight challenges that arise when diagnosing patients with peripheral T-cell lymphoma and how molecular testing results influence induction and consolidation treatment approaches for patients with ALK-negative anaplastic large cell lymphoma.

DZD8586 showcased antitumor activity and favorable safety with limited grade 3 or greater treatment-emergent adverse effects in patients with heavily pretreated B-cell non-Hodgkin lymphoma, according to preliminary findings from a pooled analysis of two ongoing phase 1 trials.

NX-2127 showcased early efficacy in the form of responses with an acceptable toxicity profile in patients with relapsed or refractory B-cell malignancies, according to data from the ongoing phase 1 NX-2127-001 trial.

David J. Andorsky, MD, discusses recently observed patterns of care with BTK inhibitors in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma in the community setting in the United States, and how social determinants of health may have affected these outcomes.