October 28th 2025
The FDA's CRL for the HyNap formulation of dasatinib due to manufacturing issues does not affect the efficacy or availability of standard dasatinib.
October 27th 2025
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.
October 24th 2025
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.
October 23rd 2025
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.
October 20th 2025
Based on the Good Manufacturing Practice observations, the FDA has given a complete response letter for dasatinib for patients with CML/ALL.
Matched donor allogeneic CAR T for adult B-ALL: toxicity, efficacy, repeat dosing, and the importance of lymphodepletion
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.
FDA Grants Fast Track Designation to UB-VV111 in Select B-Cell Malignancies
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.
Indirect Comparison Favors Zanubrutinib vs Venetoclax Combo in CLL/SLL
An indirect comparison supports continuous therapy with zanubrutinib as a valuable treatment option in treatment-naïve CLL or SLL.
Ziftomenib Shows Significant Benefit in Relapsed/Refractory NPM1+ AML
Data from KOMET-001 support ziftomenib as a new potential option for patients with relapsed/refractory NPM1-mutated acute myeloid leukemia.
Evaluating Single-Agent Ziftomenib’s Performance in NPM1+ R/R AML
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.
Pirtobrutinib Improves PFS in Treatment-Naïve CLL/SLL Without 17p Deletions
Results from the phase 3 BRUIN CLL-313 trial show that OS trended favorably for pirtobrutinib vs chemoimmunotherapy in this CLL and SLL population.
Outlining Historical Standards for Treatment in Newly Diagnosed CML
The toxicity profile of interferon and the limited availability of transplantation established a need for TKI development for chronic myeloid leukemia.
Recapping A Quarter Decade of Chronic Myeloid Leukemia Therapy
Jorge Cortes, MD, believes that, despite the rapid improvements made in CML treatment, there is always more to be done to help patients.
AI Prognostic Tool Confirms Concordance Through Epigenomic Signatures in AML
Both experimental models significantly improved upon historical clinical risk trial groups for patients with acute myeloid leukemia.
Tuspetinib Exhibits Enhanced Efficacy in Diverse Newly Diagnosed AML Group
No minimal residual disease-negativity was observed with tuspetinib in patients with AML, including in a patient with more than 7 months of follow-up data.
Taking the Next Steps to Advance Supportive Care in Leukemia
Experts at the 2025 National ICE-T Conference discussed the need for improved management of toxicities in patients with leukemia.
National ICE-T Conference Aims to Make CAR T Safer and More Available
Leading experts gathered in Orlando, Florida, to discuss the current and future state of cellular therapy in oncology at the 2025 ICE-T Symposium.
Durable Response to CAR T is Associated With Elevated Activation and Clonotypic Expansion of the Cytotoxic Native T Cell Repertoire
Researchers have identified the transcription factor CEBPA as a crucial regulator of immune recognition in acute myeloid leukemia.
Pirtobrutinib Yields Noninferior ORR Vs Ibrutinib in CLL/SLL
Data from the phase 3 BRUIN CLL-314 trial show a progression-free survival trend favoring pirtobrutinib compared with ibrutinib in patients with CLL/SLL.
sNDA Submitted to FDA for Venetoclax Plus Acalabrutinib in Untreated CLL
AMPLIFY trial results form the basis of the submission, with venetoclax/acalabrutinib showing a PFS advantage vs chemoimmunotherapy in patients with CLL.
Generic Ibrutinib Tablets Earn Tentative FDA Approval in Blood Cancers
Ibrutinib tablets will become available at 140 mg, 280 mg, and 420 mg for patients with chronic lymphocytic leukemia and Waldenström macroglobulinemia.
European Commission Grants Marketing Authorization to Obe-Cel in R/R B-ALL
Results from the phase 1b/2 FELIX trial demonstrated that obe-cel was efficacious and safe as therapy for relapsed/refractory B-cell precursor acute lymphoblastic leukemia.
Tambiciclib Plus Ven/Aza Met All Primary End Points in R/R AML Trial
The FDA has asked tambiciclib’s developer to start a trial investigating the combination in front-line acute myeloid leukemia.
FDA Accepts sNDA for Decitabine/Cedazuridine Combo in Newly Diagnosed AML
A PDUFA date for decitabine/cedazuridine and venetoclax in newly diagnosed AML has been set for February 25, 2026.
IDH Triplet Therapy Shows Excellent Outcomes in IDH-Mutant AML
Current data support prospective studies comparing IDH triplet vs IDH doublet therapies among patients with IDH-mutant acute myeloid leukemia.
FDA Grants Priority Review to Revumenib in R/R NPM1-Mutant AML
The FDA has set a Prescription Drug User Fee Act date of October 25, 2025, for approving revumenib in this acute myeloid leukemia population.
Novel BTK Degrader Shows Activity in CLL/SLL Regardless of Mutation Status
Current findings from the phase 1/2 CaDAnCe-101 trial show no predictive factors of improved responses with BGB-16673 in patients with CLL or SLL.
More Research Needed to Ascertain Ziftomenib’s Mechanism of Action in AML
Multiple mutations and gene alterations make targeted therapy development more difficult for patients with AML, according to Amir Fathi, MD.
Bexobrutideg Achieves High Objective Response Rate in Heavily Pretreated R/R CLL
Bexobrutideg, a novel BTK degrader, demonstrated preliminary clinical activity and a consistent safety profile in patients with relapsed/refractory chronic lymphocytic leukemia.
Olutasidenib Maintenance Shows Clinically Meaningful Activity in IDH1-Mutated AML
Single-agent olutasidenib maintenance demonstrated clinically meaningful activity in patients with IDH1-mutated acute myeloid leukemia.
Ponatinib Shows Clinical Benefit Over Imatinib in MRD-Positive Ph+ ALL Post Induction
Ponatinib extended EFS and PFS in patients with newly diagnosed, Ph-positive acute lymphoblastic leukemia who did not achieve MRD negativity after induction.
Oral Venetoclax Combo Elicits Responses, Survival in Newly Diagnosed AML
Data from ASCERTAIN-V may support venetoclax plus decitabine/cedazuridine as a new standard of care in those with AML ineligible to receive chemotherapy.
Dasatinib Misses Survival End Points in Core-Binding Factor AML
Compared with standard therapy, dasatinib did not improve efficacy for patients with core-binding factor AML.
Revumenib Plus Azacitidine/Venetoclax Appears Safe in Older NPM1/KMT2Ar AML
The VIALE-A trial showed high activity with revumenib plus azacitidine and venetoclax for patients with NPM1m/KMT2Ar AML.
Ziftomenib Shows MRD-Negative Responses in Pretreated NPM1+ AML
The KOMET-001 trial meets its primary end point of CR/CRh rate among patients with NPM1-mutated acute myeloid leukemia.