Leukemia

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.

Based on the Good Manufacturing Practice observations, the FDA has given a complete response letter for dasatinib for patients with CML/ALL.

A phase 1 trial is evaluating UB-VV111 with and without rapamycin as treatment for patients with CLL and LBCL who received at least 2 prior therapies.

An indirect comparison supports continuous therapy with zanubrutinib as a valuable treatment option in treatment-naïve CLL or SLL.

Data from KOMET-001 support ziftomenib as a new potential option for patients with relapsed/refractory NPM1-mutated acute myeloid leukemia.

Single-agent ziftomenib achieved an ORR of 35% in patients with relapsed/refractory acute myeloid leukemia harboring an NPM1 mutation.

New targeted therapies are needed to improve outcomes for patients with NPM1-mutant relapsed/refractory acute myeloid leukemia.

Ziftomenib yielded a median overall survival of 16.4 months in responders with NPM1-mutant AML who received ziftomenib in the phase 1b/2 KOMET-001 trial.

Results from the phase 3 BRUIN CLL-313 trial show that OS trended favorably for pirtobrutinib vs chemoimmunotherapy in this CLL and SLL population.

The medical characteristics of a patient may heavily factor into the selection of tyrosine kinase inhibition for the treatment of chronic myeloid leukemia.

The toxicity profile of interferon and the limited availability of transplantation established a need for TKI development for chronic myeloid leukemia.

Jorge Cortes, MD, believes that, despite the rapid improvements made in CML treatment, there is always more to be done to help patients.