Hematologic Oncology

The FDA has approved ziftomenib for NPM1-positive acute myeloid leukemia, has accepted a NDA for 177Lu-edotreotide for GEP-NETs, and more.

Ziftomenib has received FDA approval for the treatment of adult patients with relapsed or refractory acute myeloid leukemia harboring an NPM1 mutation.

The FDA granted RMAT designation to MB-105 for CD5-positive relapsed/refractory T-cell lymphoma.

Phase 2 data showed high 2-year survival and deep MRD-negative remissions with a CD22/CD19 CAR T-cell therapy and ASCT “sandwich” approach in B-ALL.

The FDA has approved generic dasatinib tablets for select patients with chronic myeloid leukemia and acute lymphoblastic leukemia.

Pule Wang, MD, discusses safety data with CNS bridging radiotherapy before CAR T in B-cell lymphoma.

Justin Taylor, MD, discusses findings from a study that evaluated the ability of ChatGPT to offer specific information in hematologic malignancies.

The FDA has granted orphan drug designation to M2T-CD33 for the treatment of patients with acute myeloid leukemia.

Belzutifan-based combinations meet end points in RCC, imaging agent under review for SSTR-positive neuroendocrine tumors, and more.

Here is your guide to all therapeutic options that were approved by the FDA in October 2025 spanning tumor types.

Harry P. Erba, MD, PhD; and Jayastu Senapati, MBBS, discuss the effects of drug shortages in hematologic oncology and how to adapt practice when they arise.

Pule Wang, MD, discusses findings from a retrospective study of CNS bridging radiation therapy prior to CAR T-cell therapy in B-cell lymphomas.

The FDA has cleared BVd for multiple myeloma and revumenib for NPM1-mutant AML, and granted priority review to perioperative enfortumab vedotin in MIBC.

The FDA approved revumenib for adult and pediatric patients at least 1 year of age with relapsed or refractory AML with a susceptible NPM1 mutation.

Pule Wang, MD, discusses the design of a retrospective study of CNS bridging radiation therapy prior to CAR T in B-cell lymphomas.

Dr Wang discusses the prevalence of secondary AML, unmet needs for patients with this disease, and how CPX-351 has generated improved outcomes vs 7+3.

The FDA granted fast track to EO2463, an OncoMimics immunotherapy, for low–tumor burden follicular lymphoma in the watch-and-wait setting.

XS003 shows bioequivalence to nilotinib at half the dose with a reduced food effect for patients with CML.

CAR2219 induced high response rates in relapsed/refractory LBCL, and the role of post-infusion maintenance therapy is worthy of further study.

Taylor Brooks, MD, discusses data that supported the FDA approvals of liso-cel across LBCL treatment settings and details of the agent’s toxicity profile.

Aaron Gerds, MD, MS, discusses the role of BTK inhibitors in CLL, real-world data with CAR T-cell therapies in LBCL, and JAK inhibitors for myelofibrosis.

Bezuclastinib received breakthrough therapy designation for pretreated non-advanced systemic mastocytosis, as well as for smoldering systemic mastocytosis.

The EMA’s CHMP has recommended the approval of asciminib for Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase.

Pule Wang, MD, discusses CNS bridging radiotherapy prior to CAR T-cell therapy in B-cell lymphomas.

Acalabrutinib plus lenalidomide and rituximab displayed activity and had a tolerable safety profile in first-line follicular lymphoma.