Hematologic Oncology

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 National Institute for Health and Care Excellence has recommended the use of tisagenlecleucel in pediatric B-cell acute lymphoblastic leukemia.

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

Prophylactic treatment with RGI-2001 plus tacrolimus and methotrexate led to a lower incidence of acute GVHD vs CIBMTR control following allo-HSCT.

Tamibarotene plus azacitidine and venetoclax has received FDA fast track designation for newly diagnosed, unfit, RARA-overexpressed AML.

Andrew Kuykendall, MD, and Raajit K. Rampal, MD, PhD, conclude that the increasing complexity in myelofibrosis treatment options, including multiple JAK inhibitors and emerging combination therapies, signals an exciting era of individualized care, yet underscores the need for reevaluating study end points to enhance patient outcomes further.

Andrew Kuykendall, MD, emphasizes the importance of individualizing therapy for patients with myelofibrosis, focusing on improving quality of life and addressing specific issues like anemia and spleen volume, with the understanding that these treatments are palliative and goals should be revisited regularly.

Dipti Patel-Donnelly, MD, discusses key factors to consider when selecting consolidation therapies in high-risk hematologic malignancies.

The FDA has accepted for review the new drug application for SH-201 for the treatment of patients with certain forms of leukemia and other cancers.

Eduardo M. Sotomayor, MD, discusses updates in the treatment of hematologic malignancies, highlighting research on antibody-drug conjugate and bispecific antibody combinations.

Jasmine Zain, MD, director of the T-cell Lymphoma Program, professor of hematology and hematopoietic stem cell transplantation, of City of Hope National Medical Center, discusses the challenges of treatment for patients with T-cell lymphoma.

Andrew Ip, MD, discusses the implications of using next-generation sequencing alongside machine learning in the diagnosis of hematologic malignancies.

Phase 2 data from the AUGMENT-101 study show that revumenib elicits responses with acceptable safety in pediatric patients with KMT2A+ acute leukemia.

Eduardo M. Sotomayor, MD, expands on the evolving treatment paradigm for hematologic malignancies, highlighting treatment with CAR T-cell therapy.

Sagar Patel, MD, discusses the utility of the Orca-T platform in patients with hematologic malignancies, highlighting the platform's safety.

Raajit K. Rampal, MD, PhD, discusses choosing among JAK inhibitors based on specific patient needs, such as platelet counts and anemia, emphasizing the importance of using the full dose for best efficacy and how different scenarios might influence the choice and sequencing of these drugs in practice.

Andrew Kuykendall, MD, discusses the efficacy and adverse effects of fedratinib, highlighting its potential in the second-line setting for patients resistant to ruxolitinib, with updates from FREEDOM-2 emphasizing manageable gastrointestinal tolerability concerns.

Looking to the future, Lori A. Leslie, MD, offers closing thoughts on unmet needs and potential improvements in the lymphoma treatment space.

Clinical insights on managing adverse events associated with CAR T-cell therapy and measuring patient response, highlighting a phase 2 trial on prophylactic anakinra.

The EMA has accepted a MAA seeking the approval of obe-celf or use in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia.

The FDA has approved danicopan as add-on therapy to ravulizumab or eculizumab for extravascular hemolysis in paroxysmal nocturnal hemoglobinuria.

Voruciclib plus venetoclax had antileukemic activity with acceptable safety in patients with relapsed or refractory acute myeloid leukemia.

Elias Jabbour, MD, expands on the significance of ponatinib’s approval in Philadelphia chromosome–positive acute lymphoblastic leukemia.

Sunil Iyer, MD, expands on the potential role of imetelstat for select patients with lower-risk myelodysplastic syndrome.

Hana Safah, MD, and Corey Cutler, MD, MPH, conclude with clinical insights on addressing medication access and the supportive care needs of patients with GvHD.

Guenther Koehne, MD, PhD, discusses research efforts to overcome resistance to CAR T-cell therapy in hematologic malignancies.

Drs Rampal and Kuykendall highlight the benefits of pacritinib for patients with low platelet counts, as evidenced by the PERSIST-2 study, and momelotinib for patients with anemia, as shown in the MOMENTUM Phase 3 Study, focusing on their efficacy in spleen volume reduction and symptom relief in patients with myelofibrosis.

Andrew Kuykendall, MD, and Raajit K. Rampal, MD, PhD, reflect on the future of combination therapies in treating myelofibrosis, emphasizing the need to align study endpoints with treatment goals and highlighting the potential of various combinations based on promising preclinical and early phase study results.

The FDA granted priority review to the NDA seeking the approval of revumenib for the treatment of relapsed/refractory, KMT2A-rearranged acute leukemia.