Hematologic Oncology

The FDA has extended the review period for a new drug application for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of newly diagnosed adult patients with FLT3-ITD–positive acute myeloid leukemia.

To evaluate the prevalence of financial toxicity and observe the effect of Coverage and Cost-of-Care Links, a program providing financial navigation, investigators initiated a nonrandomized study.

Michael Andreeff, MD, PhD, discusses the rationale for investigating uproleselan plus venetoclax and azacitidine in patients with acute myeloid leukemia.

Brian C. Ball, MD, discusses previous research on tamibarotene in newly diagnosed acute myeloid leukemia, and how these data support the ongoing phase 2 SELECT-AML-1 trial.

An independent data monitoring committee has recommended that the phase 3 REGAL trial examining galinpepimut-S in patients with acute myeloid leukemia continue as planned without modifications.

Mitchell E. Horwitz, MD, discusses the significance of omidubicel as an FDA-approved treatment option to reduce the risk of infection in patients with blood cancers and highlights key findings from the pivotal phase 3 trial.

The FDA has approved omidubicel-onlv (Omisirge) to quicken the recovery of neutrophils in the body and reduce the risk of infection in adults and pediatric patients aged 12 years and older with blood cancers who are slated to undergo umbilical cord blood transplantation after a myeloablative conditioning regimen.

The combination of tafasitamab and lenalidomide followed by tafasitamab maintenance prolonged responses in patients with relapsed/refractory diffuse large B-cell lymphoma.

Bradley W. Christensen, MD, discusses the process of patient selection for BCL-2 induction therapy in patients with acute myeloid leukemia in accordance with their individual disease characteristics.

The FDA has placed a partial clinical hold on a phase 1 trial investigating MT-0169 in patients with relapsed/refractory multiple myeloma or non-Hodgkin lymphoma.

Elias Jabbour, MD; Harry Paul Erba, MD, PhD; Anjali Advani, MD; and Sameem Abedin, MD, discuss key updates pertaining to the leukemia treatment landscape that were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition.

Mark Levis, MD, PhD, discusses potential changes to the FLT3-ITD-mutated acute myeloid leukemia treatment landscape that may occur if the FDA approves quizartinib, key efficacy and safety data with the agent, and how quizartinib compares with midostaurin.

Craig Sauter, MD, discussed the common limitations of CAR T-cell therapy through timely referral and the existing questions for patients with LBCL who progress on CAR T-cell therapy.

Jorge E. Cortes, MD, discusses the importance of defining fitness in patients with hematologic malignancies prior to treatment selection.

Bradley W. Christensen, MD, discusses findings from the phase 3 VIALE-A trial in patients with acute myeloid leukemia.

Hematologists and oncologists are uniquely poised to aid in the identification of patients with hereditary hemorrhagic telangiectasia and assist in their care, and it is important for the practicing clinician to familiarize oneself with the symptoms of hereditary hemorrhagic telangiectasia to avoid overlooking the diagnosis.

Closing out their discussion on the management of acute myeloid leukemia, expert panelists share their excitement for the future evolution of the treatment landscape.

A comprehensive review of emerging treatment options and how they may fit into the treatment landscape of acute myeloid leukemia.

Eunice Wang, MD, discusses the current standards for classifying and treating unfit patients with AML, treatment considerations for patients unfit for hypomethylating agents, and the potential role of investigational menin inhibitors and immunotherapies in this population.

Mayur Narkhede, MD, discusses the early findings for the use of siltuximab to manage cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome in patients following CAR T-cell therapy and expands on the next steps for investigating this agent during the phase 2 trial.

The FDA has granted an orphan drug designation to EP0042 for use as a potential therapeutic option in patients with acute myeloid leukemia with acquired resistance to FLT3 inhibitors.

Craig Sauter, MD, discusses where BTK inhibitors could fit into the frontline treatment landscape for patients with central nervous system lymphoma and research aiming to address other unmet needs for this patient population.

Shared insight on how treatments can be optimally sequenced in patients with relapsed/refractory acute myeloid leukemia.

Expert perspectives on the potential role of IDH1-targeted therapy, olutasidenib, in patients with relapsed/refractory acute myeloid leukemia.

The FDA has approved nelarabine for injection for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma, according to an announcement from Shorla Oncology.

Heterogeneous patterns of polycythemia vera management indicate the need for continued research in this disease and increased guideline specificity across treatment centers in Italy.

Soligenix has submitted a Type A meeting request to the FDA to discuss the contents of a refusal to file letter from the regulatory agency regarding the new drug application for synthetic hypericin for the treatment of early-stage cutaneous T-cell lymphoma.

Experts close by summarizing key advances and remaining unmet needs across all MDS risk groups, and share their hopes for the future.

A brief discussion centered on MDS/MPN-RS-T overlap syndromes, considerations for diagnosis, available treatment options, and updates in the space.

The FDA’s Office of Therapeutic Products has accepted a resubmission of the biologics license application (BLA) for remestemcel-L for the treatment of pediatric patients with steroid-refractory, acute graft-vs-host-disease.