Hematologic Oncology

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.

A meta analysis found BTK inhibitors carry risks of hypertension, atrial fibrillation, and hemorrhage, underscoring the need for cardiovascular monitoring.

Preview the top lung, breast, GI, GU, gynecologic, and hematologic oncology abstracts and topics ahead of the 2025 ESMO Congress.

The FDA approved adjuvant cemiplimab in cutaneous squamous cell carcinoma, issued a CRL to dasatinib in chronic myeloid leukemia, and more.

The removal of REMS programs for approved CAR T-cell therapies could enable improved access and streamlined management of hematologic malignancies.

The FDA has issued a CRL for dasatinib, a next-generation formulation of a protein kinase inhibitor, for the treatment of patients with chronic myeloid leukemia.

A Data Monitoring Committee confirmed that the safety profile of HyBryte is acceptable and that the agent is not associated with safety concerns in CTCL.

The FDA granted priority review to a biologics license applications seeking the approval of Orca-T for select hematologic malignancies.

The FDA clears maintenance lurbinectedin combination in lung cancer, T-DxD sBLA in HER2-positive breast cancer is accepted for review, and more.

A mogamulizumab-based combination led to complete remission in a patient with CAR-positive T-cell lymphoma with CCR4 overexpression.

Here is your Q4 2025 preview spotlighting 10 FDA decisions to watch, including upcoming PDUFAs for belantamab mafodotin, revumenib, sevabertinib, and more.

Multiple myeloma and non-Hodgkin lymphoma emerge as key hematology topics ahead of ESMO 2025, followed by MPNs and T-cell lymphoma.

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