AML

If approved, ziftomenib could be the first FDA-approved Menin inhibitor for relapsed/refractory acute myeloid leukemia with an NPM1 mutation.

The first patient in a trial received oral zelenirstat, a N-myristoyltransferase inhibitor, to determine its safety and tolerability in relapsed/refractory AML.

Patients with AML aged 80 years and older face poor survival despite treatment advances, highlighting the need for improved, equitable care strategies and tailored treatment approaches.

The phase 3 REGAL trial of galinpepimut-S in acute myeloid leukemia can proceed without modifications, based on findings from the prespecified interim analysis of the study.

The FDA granted galinpepimut-S a rare pediatric disease designation for the treatment of pediatric patients with acute myeloid leukemia.

BL-M11D1, a CD33-binding antibody-drug conjugate, is being evaluated for the treatment of patients with acute myeloid leukemia.

Sangeetha Venugopal, MD, MS, discussed the evolving landscape of acute myeloid leukemia treatment as well as unmet needs among these patients.

Following a futility analysis, the phase 2 SELECT-AML-1 trial of tamibarotene combined with venetoclax and azacitidine in newly diagnosed RARA-overexpressed acute myeloid leukemia will discontinue enrollment.

The FDA has granted a rare pediatric disease designation to SLS009 for treating pediatric acute myeloid leukemia.

The completion of the End of Phase 2 meeting for the phase 1B/2 trial of annamycin and cytarabine in acute myeloid leukemia has been announced.

The FDA granted a rare pediatric disease designation to a promising new drug, SLS009, for the treatment of pediatric leukemia.

An investigational new drug application for lomonitinib has been cleared by the FDA for FLT3-mutated relapsed/refractory AML treatment, and a phase 1 trial evaluating the agent will begin in the US.

A phase 3 study evaluating uproleselan in relapsed/refractory acute myeloid leukemia missed its primary end point of overall survival.

With an FDA orphan drug designation now granted to IGNK001, clinical trials investigating the agent in acute myeloid leukemia are planned to initiate in the US.

Cellular therapies are an effective option in hematologic malignancies but have been slower to develop in AML, but identifying new targets paves the way for evolving treatments.

This breakthrough therapy designation of ziftomenib marks the first of its kinds in NPM1-mutant acute myeloid leukemia.

A phase 1/2 trial showed that SLS009 in combination with azacitidine and venetoclax achieved a 50% response rate in relapsed/refractory acute myeloid leukemia.

The FDA granted orphan drug designation to LYT-200, a drug being investigated for treating acute myeloid leukemia.

The phase 1 study of HEMO-CAR-T in patients with acute myeloid leukemia can proceed following the lifted clinical hold.

Magrolimab will no longer be in development as a treatment option for patients with hematologic malignancies.

In an interview with Targeted Oncology, Ashley Yocum, PhD, discussed The Beat AML study and emphasized the significance of considering patient factors, such as age and genetic mutations, in treatment decisions.

In an interview with Targeted Oncology, Naval G. Daver, MD, discussed the first-in-human, phase 1/2 study of DSP-5336 in patients with relapsed or refractory acute myeloid leukemia.

PTX-252, a novel molecular drug, has received an FDA orphan drug designation for the treatment of patients with acute myeloid leukemia.

The novel CDK9 inhibitor previously received orphan drug designations in relapsed/refractory acute myeloid leukemia and peripheral T-cell lymphoma.

Orca-T, an allogeneic hematopoietic cell transplant biologic designed to control alloreactive immune responses, led to less graft-vs-host disease and favorable overall survival and relapse-free survival in patients with intermediate- and high-risk myelodysplastic syndrome.