Leukemia

A generic version of ibrutinib was granted tentative approval by the FDA for use in CLL and SLL with 17p deletion and Waldenström macroglobulinemia.

The FDA removed REMS and reduced certain monitoring needs for liso-cel and ide-cel in B-cell malignancies.

An oral tablet formulation of zanubrutinib was approved for use in patients with certain lymphomas or leukemia and Waldenström macroglobulinemia.

A network meta-analysis suggests zanubrutinib may offer improved efficacy over other BTK inhibitors for patients with high-risk relapsed/refractory CLL.

Gene expression in peripheral blood as well as patient-reported outcomes differed for those with acute myeloid leukemia undergoing induction chemotherapy.

AUTX-703, a novel, oral KAT2A/B degrader, has received fast track designation for use in relapsed/refractory AML.

January's FDA oncology approvals offer new treatment options for breast cancer, mantle cell lymphoma, and other malignancies.

Treosulfan plus fludarabine was approved by the FDA for children and adults with AML or MDS before allogenic hematopoietic stem cell transplantation.

The FELIX trial demonstrated that obe-cel induced durable remissions in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

The combination of revumenib plus decitabine/cedazuridine showed high rates of remission among patients with relapsed/refractory AML with KMT2Ar, NPM1mt, and NUP98r genetic alterations.

Treatment sequencing with targeted therapies may help to improve overall survival, according to real-world data.

Following risk management measures, ponatinib-associated adverse events in CML and ALL were shown to have decreased significantly since the drug’s approval.

Treatment with pirtobrutinib induced superior progression-free survival among heavily pretreated patients with relapsed or refractory CLL/SS previously treated with a covalent BTK inhibitor.

Secondary end points of the ASC4FIRST trial continue to show superior results with the use of asciminib, over standard-of-care TKIs in CML.

Treatment with acalabrutinib plus venetoclax, with or without obinutuzumab, improved PFS over standard-of-care chemoimmunotherapy in patients with treatment-naive CLL.

Treatment with epcoritamab alone demonstrated deep responses in heavily pretreated patients with CLL, according to the expansion and optimization cohorts in the EPCORE CLL-1 trial.

Long-term follow-up showed continued meaningful responses in patients with relapsed or refractory KMT2Ar acute leukemia who were treated with revumenib, with no new safety signals found.

Treatment with bicistronic CD19/CD22-directed CAR T-cell therapy appeared safe and effective with high remission rates among children with relapsed/refractory B-ALL.

Meta: Blinatumomab plus chemotherapy, vs chemotherapy alone, significantly improved DFS rates and was well tolerated in pediatric patients with standard-risk pediatric B-ALL.

The FDA has granted fast track designation to LBS-007 for the treatment of patients with acute myeloid leukemia.

An expert discusses the FDA approval of obecabtagene autoleucel—the only CAR T-cell therapy given via split dosing for patients with ALL.

The FDA approved an oral solution of imatinib for multiple different cancer types.

The FDA approved an updated drug label for fludarabine phosphate for the treatment of B-cell chronic lymphocytic leukemia.

The FDA approved ninlotinib tablets that do not have mealtime restrictions for Ph-positive CML in chronic phase and CML that was previously treated.

The FDA approved obecabtagene autoleucel (obe-cel; Aucatzyl) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Brexu-cel is effective in treating patients with relapsed/refractory B-cell acute lymphoblastic leukemia, real-world data shows.

The FDA expanded the approval of methotrexate to include patients with pediatric acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis.

The FDA granted an accelerated approval to asciminib for newly diagnosed Ph+ chronic myeloid leukemia in the chronic phase.

The FDA granted a fast track designation to HC-7366 for adults with relapsed or refractory acute myeloid leukemia.

Asciminib is a promising agent for frontline chronic myeloid leukemia, Jorge Cortes, MD, explained.