Hematologic Oncology

The FDA has granted priority review to asciminib for newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase.

Dan Pollyea, MD, MS, discusses the mechanism of action for the menin inhibitor revumenib in KMT2A-rearranged relapsed/refractory acute myeloid leukemia.

The FDA has extended the PDUFA date for the NDA seeking the approval of revumenib for patients with relapsed/refractory KMT2A-rearranged acute leukemia.

Blinatumomab added to consolidation chemotherapy led to a significant OS benefit in MRD-negative B-cell precursor acute lymphoblastic leukemia.

Justin M. Watts, MD, discusses the design and purpose of a phase 1 trial evaluating INCB057643 in myelofibrosis and other advanced myeloid neoplasms.

Iopofosine I 131 generated a major response rate of 56.4% in patients with relapsed/refractory Waldenström macroglobulinemia.

The FDA has accepted the resubmission of a BLA for remestemcel-L in pediatric steroid-refractory acute graft-vs-host-disease.

A Phase 1b study (NCT03013998) to determine the safety and recommended dose of Revumenib combined with Aza/Ven in patients with newly diagnosed AML ≥ 60 years old with NPM1mut or KMT2Ar and who are not candidates or do not wish to pursue intensive induction therapy.

Justin M. Watts, MD, discusses 5-year efficacy and safety data for olutasidenib in IDH1-mutant, relapsed/refractory AML.

Mazyar Shadman, MD, MPH, discusses the rationale for combining sonrotoclax plus zanubrutinib for treatment-naive chronic lymphocytic leukemia.

Craig Eckfeldt, MD, PhD, discusses how improved minimal residual disease testing methods have impacted the acute myeloid leukemia treatment paradigm.

Mark Juckett, MD, discusses ways the treatment paradigm has changed for patients with relapsed/refractory acute myeloid leukemia.

Timothy Hughes, MD, MBBS, FRACP, FRCPA, on safety data for asciminib in Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia.

Dr. Hannah Choe discusses a clinical scenario of a patient with GVHD who has progressed after multiple lines of treatment. She explores how the availability of CSF-1R inhibitors could fit into the evolving treatment landscape for managing this difficult-to-treat patient population. Dr. Choe provides her perspectives on the potential role and clinical implications of targeting this pathway as an emerging therapeutic approach for GVHD.

Dr. Hannah Choe reviews data from the AGAVE-201 trial investigating the CSF-1R inhibitor axatilimab, including efficacy, safety, and clinical implications of these data for patients with recurrent or refractory chronic GVHD.

Odronextamab elicited deep, durable responses in heavily pretreated patients with relapsed/refractory follicular lymphoma.

Brentuximab vedotin plus lenalidomide/rituximab (R2) provided a superior overall survival benefit vs R2 alone in relapsed/refractory DLBCL.

The BLA for tabelecleucel has been granted priority review for the treatment of patients with Epstein-Barr virus–positive post-transplant lymphoproliferative disease.

Grzegorz S. Nowakowski, MD, discusses the significance of the FDA approval of epcoritamab in relapsed/refractory follicular lymphoma.

Francisco Hernandez-Ilizaliturri, MD, discusses selection and sequencing considerations for bispecific antibodies and CAR T-cell therapies in DLBCL.

The FDA has placed a partial clinical hold on a trial evaluating seclidemstat plus azacitidine in myelodysplastic syndromes or chronic myelomonocytic leukemia.

Francisco Hernandez-Ilizaliturri, MD, details factors that influence CAR T-cell therapy selection in relapsed/refractory follicular lymphoma.

The investigational menin-MLL inhibitor DSP-5336 has received FDA fast track designation in KMT2A-rearranged/NPM1-mutant acute myeloid leukemia.

Moleculin Biotech completed an end-of-phase 2 meeting with the FDA regarding the investigation of annamycin plus cytarabine in acute myeloid leukemia.

Pamela J Sung, MD, PhD, details differentiation therapy in acute myeloid leukemia, focusing on newer targets and preclinical evidence for a novel FLT3 combination.