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 Obinutuzumab for Previously Untreated Follicular Lymphoma Nov 16, 2017

    On November 16, 2017, the Food and Drug Administration granted regular approval to obinutuzumab (GAZYVA®, Genentech, Inc.) in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma.

  • FDA Approves Emicizumab-kxwh for Prevention and Reduction of Bleeding in Patients With Hemophilia A With Factor VIII Inhibitors Nov 16, 2017

    On November 16, 2017, the Food and Drug Administration approved emicizumab-kxwh (HEMLIBRA®, Genentech, Inc.) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

  • FDA Approves Dasatinib for Pediatric Patients With CML Nov 09, 2017

    On November 9, 2017, the Food and Drug Administration granted regular approval to dasatinib (SPRYCEL®, Bristol-Myers Squibb Co.) for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.

  • FDA Approves Brentuximab Vedotin for the Treatment of Adult Patients with Primary Cutaneous Anaplastic Large Cell Lymphoma Nov 09, 2017

    On November 9, 2017, the Food and Drug Administration granted regular approval to brentuximab vedotin (ADCETRIS, Seattle Genetics, Inc.) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

  • FDA Approves First Drug for Prophylaxis of Cytomegalovirus Infection and Disease in Bone Marrow Transplant Patients Nov 09, 2017

    On Nov. 8, 2017, the Food and Drug Administration approved Prevymis (letermovir) tablets and injection, the first drug indicated to help prevent CMV (cytomegalovirus) infection and disease in adults who have been exposed to CMV and have received an allogeneic hematopoietic stem cell (bone marrow) transplant.

  • FDA Approves Vemurafenib for Erdheim-Chester Disease Nov 06, 2017

    On November 6, 2017, the Food and Drug Administration granted regular approval to vemurafenib (ZELBORAF, Hoffmann-La Roche Inc.) for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation.

  • FDA Grants Accelerated Approval to Acalabrutinib for Mantle Cell Lymphoma Oct 31, 2017

    On October 31, 2017, the Food and Drug Administration granted accelerated approval to acalabrutinib (Calquence™, AstraZeneca Pharmaceuticals Inc. under license of Acerta Pharma BV) for treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

  • FDA Approves Axicabtagene Ciloleucel for Large B-Cell Lymphoma Oct 19, 2017

    On October 18, 2017, the U.S. Food and Drug Administration granted regular approval to axicabtagene ciloleucel (YESCARTA™, Kite Pharma, Inc.) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

  • FDA Simplifies IRB Requirements for Individual Patient Expanded Access Oct 03, 2017

    On October 3, 2017, the U.S. Food and Drug Administration (FDA) announced updates to three final guidance documents, including Form FDA 3926 and its instructions, to simplify Institutional Review Board (IRB) review requirements for physicians seeking to treat an individual patient with an investigational drug under expanded access. The updates allow for a waiver of the requirement for review and approval at a convened IRB meeting if the physician instead obtains concurrence by the IRB chairperson (or a designated IRB member) before treatment use begins.

  • FDA Grants Accelerated Approval to Copanlisib for Relapsed Follicular Lymphoma Sep 14, 2017

    On September 14, 2017, the U.S. Food and Drug Administration granted accelerated approval to copanlisib (ALIQOPA™, Bayer HealthCare Pharmaceuticals Inc.) for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.

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