Non-Hodgkin Lymphoma

The pending biologics license application and supplemental new drug application seeking the approval of the combination of ublituximab and umbralisib in adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma has been voluntarily withdrawn by TG Therapeutics, Inc.

A small proportion of a subset of patients with chronic lymphocytic leukemia acquired mechanisms of genetic resistance to the novel noncovalent BTK inhibitor pirtobrutinib, according to results from a genomic analysis of patients in the phase 1/2 BRUIN trial.

Epcoritamab was found to produce an encouraging overall response rate in patients with relapsed or refractory large B-cell lymphoma who previously received CAR T-cell therapy.

Zanubrutinib demonstrated superiority over ibrutinib in terms of overall response rate per independent review committee assessment in adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The T-cell attributes of axicabtagene ciloleucel impacted tumor burden, efficacy outcomes, peak levels of proinflammatory cytokines, and toxicities such as neurologic events and cytokine release syndrome in patients with relapsed/refractory large B-cell lymphoma.

The innate cell engager AMF13 combined with preactivated and expanded natural killer (NK) cells induced “very encouraging activity” in patients with heavily pretreated lymphoma.

Ann S. LaCasce, MD, MMSc, discusses updates in lymphoma, myelofibrosis, and chronic lymphocytic leukemia.

The FDA has approved axicabtagene ciloleucel for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.

The Ministry of Health, Labour, and Welfare has accepted a supplemental new drug application for lisocabtagene maraleucel for the second-line treatment of patients with relapsed or refractory large B-cell lymphoma.

The FDA has discouraged the pursuit of a marketing authorization of the PI3K inhibitor zandelisib in patients with follicular lymphoma or marginal zone lymphoma, citing the need for randomized trial data.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of the approval of polatuzumab vedotin for use in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone in patients with previously untreated diffuse large B-cell lymphoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of tisagenlecleucel for use in adult patients with relapsed/refractory follicular lymphoma following 2 lines of systemic treatment.

Frederick Locke, MD, discusses the phase 3 ZUMA-7 trial examining axicabtagene ciloleucel in the second-line treatment of patients with relapsed/refractory large B-cell lymphoma, safety and efficacy findings with the therapy, and the significance of the data that have been reported to date.

Stephen M. Ansell, MD, PhD, discusses the evolving treatment landscape in diffuse large B-cell lymphoma.

Stephen Oh, MD, PhD, discusses current and emerging agents in myelofibrosis, advances in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma, updates in acute and chronic graft-vs-host-disease, and chronic lymphocytic leukemia management.

The FDA has granted an orphan drug designation to epcoritamab for use as a potential therapeutic option for patients with follicular lymphoma.

Lori A. Leslie, MD, discusses the methods utilized in the phase 3 ZUMA‑7 trial in relapsed/refractory large B-cell lymphoma.

Jason R. Westin, MD, director, discusses the utilization of CAR T-cell therapy in relapsed/refractory large B-cell lymphoma.

Although checkpoint inhibitors and bispecific antibodies have come to represent clinical oncology’s fourth leg of treatment—immunotherapy—there remains much to explore within lymphoma.

The emergence of novel agents, including CAR T-cell therapies and antibody-drug conjugates, plus existing options such as chemoimmunotherapy and bone-marrow transplant, have combined to raise questions about the sequencing of these treatments in patients with diffuse large B-cell lymphoma.

Caron A. Jacobson, MD, MMSc, and a panel of experts, talk about the evolving landscape for patients with relapsed or refractory follicular lymphoma, plus data on PI3K inhibitors and CAR T-cell therapies.

The FDA has announced that they are investigating umbralisib (Ukoniq), an oral inhibitor of PI3K-delta and CK1-epsilon that is approved to treat patients with marginal zone lymphoma and follicular lymphoma, after initial data from the phase 3 UNITY-CLL trial revealed a potential increased risk of death in those who received the agent.

The China National Medical Products Administration has accepted a supplemental new drug application for zanubrutinib as a treatment option for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B following 2 or more lines of systemic therapy.

The China National Medical Products Administration has accepted a supplemental new drug application for zanubrutinib as a treatment for adult patients with Waldenström macroglobulinemia.

Venetoclax proved to be safe and highly active when used in patients with relapsed or refractory Waldenström macroglobulinemia, including those who previously received BTK inhibitors and those harboring CXCR4 mutations.

Gilead Sciences, Inc. has decided to voluntarily withdraw the indications of idelalisib in patients with relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma who had received at least 2 prior systemic therapies.

The FDA has granted a regenerative medicine advanced therapy designation and a fast track designation to C-CAR039 for use as a potential therapeutic option in patients with relapsed or refractory diffuse large B-cell lymphoma.

John M. Burke, MD, highlights the benefits derived with polatuzumab vedotin plus R-CHP and projects the next steps for the regimen.

Tatyana Feldman, discusses the efficacy of adding etoposide to brentuximab vedotin followed by brentuximab vedotin consolidation in patients with newly diagnosed, CD30-expressing peripheral T-cell lymphomas.