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 Approves Fedratinib for Myelofibrosis Aug 16, 2019

    The Food and Drug Administration approved fedratinib (INREBIC, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).

  • Ruxience Approved for the Treatment of Adult Patients with Non-Hodgkin Lymphoma Jul 24, 2019

    The U.S. Food and Drug Administration (FDA) approved Ruxience (rituximab-pvvr), a biosimilar to U.S.-licensed Rituxan (rituximab) for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma (NHL) to be used as a single agent or in combination with chemotherapy, and CD20-positive Chronic Lymphocytic Leukemia (CLL) in combination with chemotherapy.

  • FDA Grants Accelerated Approval to Selinexor for Multiple Myeloma Jul 03, 2019

    The Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

  • FDA Approves Daratumumab for Multiple Myeloma Ineligible for Autologous Stem Cell Transplant Jun 28, 2019

    The Food and Drug Administration approved daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

  • FDA Approves Polatuzumab Vedotin-piiq for Diffuse Large B-cell Lymphoma Jun 10, 2019

    The Food and Drug Administration granted accelerated approval to polatuzumab vedotin-piiq (POLIVY, Genentech, Inc.), a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.

  • FDA Approves Addition of Survival Data to Gilteritinib Label for Refractory AML with a FLT3 Mutation May 30, 2019

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

  • FDA Approves Lenalidomide for Follicular and Marginal Zone Lymphoma May 28, 2019

    The Food and Drug Administration approved lenalidomide (REVLIMID®, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL).

  • FDA Approves Dalteparin Sodium for VTE in Pediatric Patients May 17, 2019

    The Food and Drug Administration approved dalteparin sodium (FRAGMIN, Pfizer, Inc.) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older.

  • FDA Approves Venetoclax for CLL and SLL May 16, 2019

    The Food and Drug Administration approved venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

  • Ivosidenib Approved as First-Line Treatment for AML with IDH1 Mutation May 03, 2019

    The Food and Drug Administration approved ivosidenib (TIBSOVO, Agios Pharmaceuticals, Inc.) for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.

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