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FDA Update 2024
November 15, 2024|6 min read

FDA Approves Revumenib for Relapsed or Refractory Acute Leukemia With a KMT2A Translocation

On November 15, 2024, the U.S. Food and Drug Administration (FDA) approved revumenib (Revuforj®), a menin inhibitor, for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients aged one year and older.

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October 29, 2024|5 min read

FDA Grants Asciminib Accelerated Approval for Newly Diagnosed Chronic Myeloid Leukemia

On October 29, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib (Scemblix®) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

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June 14, 2024|7 min read

FDA Approves Blinatumomab as Consolidation for CD19-Positive, Philadelphia Chromosome–Negative, B-Cell Precursor Acute Lymphoblastic Leukemia

On June 14, 2024, the U.S. Food and Drug Administration (FDA) approved blinatumomab (Blincyto®) for adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia in the consolidation phase of multiphase chemotherapy.

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March 19, 2024|5 min read

FDA Grants Accelerated Approval to Ponatinib With Chemotherapy for Newly Diagnosed Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia

On March 19, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ponatinib (Iclusig®) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.

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March 6, 2024|5 min read

FDA Approves Inotuzumab Ozogamicin for Pediatric Patients With Acute Lymphoblastic Leukemia

On March 6, 2024, the U.S. Food and Drug Administration (FDA) approved inotuzumab ozogamicin (Besponsa®) for pediatric patients aged 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

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December 1, 2023|5 min read

FDA Grants Accelerated Approval to Pirtobrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

On December 1, 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca™) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

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How Oncology Nurses Can Support Childhood Cancer Survivors
December 14, 2022|5 min read

Modernized Treatment Approaches for Childhood Cancers Are a Result of COG Clinical Trials

Significant progress has been made with childhood cancer, especially with the efforts of Children's Oncology Group (COG), but some areas still need attention, Doug Hawkins, MD, COG chair, a National Cancer Institute (NCI)-funded network of researchers and hospitals, explained in a September 2022 interview with NCI.

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November 22, 2022|5 min read

FDA Approves Second Dosing Regimen for Asparaginase Erwinia Chrysanthemi (Recombinant)-Rywn

On November 18, 2022, the U.S. Food and Drug Administration approved a Monday-Wednesday-Friday dosing option for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze®). Under the alternative regimen, patients receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings and 50 mg/m2 intramuscularly on Friday afternoons. It also is approved at a dose of 25 mg/m2 intramuscularly every 48 hours.

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New Liquid Biopsy Approach Is Accurate in Detecting Early Cancer
June 1, 2022|4 min read

Naive T-Cell Depletion Prevents Chronic GVHD in Transplantation Survivors

A novel stem cell transplantation strategy reduces both the incidence and severity of chronic graft-versus-host disease (GVHD) in patients with acute leukemia, researchers reported in the Journal of Clinical Oncology. The investigational treatment removes naïve T cells from donor cells before transplanting into patients.

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May 27, 2022|8 min read

FDA Approves Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

On May 25, 2022, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) in combination with azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 variant as detected by an FDA-approved test in adults aged 75 years or older or those who have comorbidities that preclude use of intensive induction chemotherapy.

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