AML

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.

Molecular minimal residual disease assessed after chemotherapy induction can identify patients with NPM1-mutated acute monocytic leukemia.

Results from the phase 1/2 SAVE trial demonstrated an improved objective response rate when revumenib was added to decitabine/cedazuridine, and venetoclax for patients with relapsed/refractory acute myeloid leukemia.

The required blast threshold of 20% has now been omitted from AML with defining genetic abnormalities with the exception of AML with BCR::ABL1 and AML with CEBPA mutation.

A phase 1 trial plans to be initiated in 2024 to investigate GTB-3650 for the treatment of patients with CD33-positive leukemia.

An investigational new drug application for TCB008 has been cleared by the FDA. A phase 1B trial will now assess the agent in patients with relapsed/refractory acute myeloid leukemia.

SLS009 represents a promising solution for patients with acute myeloid leukemia, addressing a significant unmet medical need. Top-line data on the agent are expected by the end of the year.

Bexmarilimab shows encouraging results when combined with standard of care treatments for patients with acute myeloid leukemia and myelodysplastic syndromes.

Based on the recommendation of an independent data monitoring committee and positive topline data, accrual in the KMT2A-rearranged cohorts of the AUGMENT-101 trial of revumenib will be stopped.