American Society of Hematology

FDA Alerts

In collaboration with the Food and Drug Administration (FDA), and as a service to our members, ASH provides information about newly approved therapies and other important FDA actions (e.g., updated safety information, new prescribing information) for patients. This allows the agency to inform hematologists and professionals in hematology-related fields of recent approvals in a timely manner. In providing this information, ASH does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.
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  • FDA Warns About the Risks Associated with the Investigational use of Venclexta in Multiple Myeloma Mar 25, 2019

    The U.S. Food and Drug Administration is alerting health care professionals, oncology clinical investigators and patients about the risks associated with the investigational use of Venclexta (venetoclax) for the treatment of patients with multiple myeloma based on data from a clinical trial. Venclexta is not approved for the treatment of multiple myeloma.

  • FDA Approves Caplacizumab-yhdp Feb 06, 2019

    On February 6, 2019, the Food and Drug Administration approved caplacizumab-yhdp (CABLIVI, Ablynx NV) for adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

  • FDA Approves Ravulizumab-cwvz for Paroxysmal Nocturnal Hemoglobinuria Jan 08, 2019

    On December 21, 2018, the Food and Drug Administration approved ravulizumab-cwvz (ULTOMIRIS, Alexion Pharmaceuticals, Inc.) for adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

  • FDA Approves Longer-Acting Calaspargase Pegol-mknl for ALL Dec 20, 2018

    On December 20, 2018, the Food and Drug Administration approved calaspargase pegol-mknl (ASPARLAS, Servier Pharmaceuticals LLC), an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years.

  • FDA Approves Romiplostim for Pediatric Patients With ITP Dec 14, 2018

    The Food and Drug Administration approved romiplostim (NPLATE, Amgen Inc.) for pediatric patients 1 year of age and older with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

  • FDA Approves Biosimilar Truxima for Non-Hodgkin Lymphoma Nov 28, 2018

    The Food and Drug Administration approved Truxima (rituximab-abbs, Celltrion Inc.) as the first biosimilar to Rituxan (rituximab, Genentech Inc.) for patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

  • FDA Approves Gilteritinib for Relapsed or Refractory AML With FLT3 Mutation Nov 28, 2018

    The Food and Drug Administration approved gilteritinib (XOSPATA, Astellas Pharma US Inc.) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

  • FDA Approves Larotrectinib for Solid Tumors With NTRK Gene Fusions Nov 26, 2018

    The Food and Drug Administration granted accelerated approval to larotrectinib (VITRAKVI, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.

  • FDA Approves Venetoclax in Combination for AML in Adults Nov 21, 2018

    The Food and Drug Administration granted accelerated approval to venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

  • Glasdegib Approved for AML with Comorbidities Nov 21, 2018

    The Food and Drug Administration approved glasdegib (DAURISMO, Pfizer Labs) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.

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