Leukemia

Ziftomenib given at 600 mg in combination with venetoclax/azacitidine produced high response rates in NPM1-mutated AML.

“Pirtobrutinib continues to show favorable efficacy and promising overall survival [OS],” said William G. Wierda, MD, PhD.

Clinical efficacy and response rates were increased with blinatumomab/ponatinib vs chemotherapy/imatinib for patients with Ph+ ALL.

The CR/CR with incomplete bone marrow recovery rate was 12.8% in patients with relapsed/refractory CLL/SLL following zanubrutinib treatment.

Investigators reported fewer dose reductions due to treatment-emergent adverse effects with pirtobrutinib vs ibrutinib in the phase 3 BRUIN CLL-314 trial.

Azacitidine plus venetoclax reduced the risk of progressive disease, persistent disease prompting therapy change, relapse, hospice, or death by 45%.

Even among Black patients with sufficient social support for clinical trial enrollment, there is inequity related to accessing allogenic transplantation.

Results from a phase 2 trial showed an ORR of 62.5% in patients receiving lisaftoclax monotherapy for CLL/SLL.

A total of 30.0% and 31.5% of families with children undergoing chemotherapy for ALL experienced household material hardship or catastrophic income loss.

Fixed-duration venetoclax regimens with obinutuzumab or ibrutinib showed noninferior PFS vs continuous single-agent ibrutinib in the phase 3 CLL17 trial.

Future work may expand analyses of measurable residual disease as a surrogate end point in AML to the use of modern, non-intensive treatment backbones.

The 2-year EFS end point was met in the cohort of patients given non-TBI conditioning and allogeneic HCT among those with B-ALL who are pre-HCT and NGS MRD-negative.

Olverembatinib plus low-intensity chemotherapy achieved an MRD-negativity rate in about 65% of patients with newly diagnosed Ph+ ALL.

Updated results at ASH 2025 may support new alternatives to continuous therapy and standard intensive chemotherapy across different leukemia types.

Phase 1 data related to CLN-049 for patients with acute myeloid leukemia will be presented at the 2025 ASH Annual Meeting and Exposition.

According to Daniel Peters, MD, the recent FDA approvals of revumenib and ziftomenib in AML are some of the most exciting developments in the field.

Among all patients with AML enrolled in the trial who received olutasidenib, the CR or CRh rate was 35%, with 55% of responders responding within 2 months.

Based on results from the ANDROMEDA study, the FDA has given traditional approval to daratumumab and hyaluronidase-fihj plus VCd in patients with newly diagnosed light chain amyloidosis.

Clinical data from the phase 1b/2 KOMET-001 trial support the agency’s approval of ziftomenib in this patient population.

The newly approved dasatinib tablets are therapeutically equivalent and approved in the same indications as reference dasatinib.

Researchers have determined that matched allogeneic donor CD19 CAR T-cell therapy, delivered as a CAR-modified donor lymphocyte infusion, is safe and clinically active for adults with relapsed B-ALL following allogeneic transplant.

The FDA's CRL for the HyNap formulation of dasatinib due to manufacturing issues does not affect the efficacy or availability of standard dasatinib.

Over the past 4 years, the FDA has accepted a number of NDA submissions for dasatinib, but it has yet to receive approval in CML/ALL.

Results from the phase 1/2 AUGMENT-101 trial support the FDA’s decision for approving revumenib in this NPM1-mutated, relapsed/refractory AML population.

The FDA has set a Prescription Drug User Fee Act date of June 18, 2026, for approving this formulation of nilotinib in chronic myeloid leukemia.