ASH Clinical News Hematology Pipeline Update | Page 3

FEBRUARY 2015 AMERICAN SOCIETY OF HEMATOLOGY HEADQUARTERS r International Inc. 2021 L Street NW, Suite 900 oration. All rights reserved. USBS/MG114/14-0049 Washington, DC 20036 www.hematology.org Tel: [phone] EDITOR-IN-CHIEF Mikkael Sekeres, MD, MS Vice-Chair for Clinical Research Director, Leukemia Program Cleveland Clinic, Taussig Cancer Institute Cleveland, OH ASSOCIATE EDITORS Beth Faiman, CNP, PhD Cleveland Clinic Cleveland, OH Hematology Pipeline Update: Newly Approved Drugs The 2014 ASH Annual Meeting included a first-of-its-kind Special Education Session on Newly Approved Drugs – an extension of the Society’s ASH/FDA webinar series on agents recently approved by the U.S. Food and Drug Administration. In each didactic presentation, physicians discussed hematologic drugs approved in 2014, in the areas of hemophilia, chronic lymphocytic leukemia (CLL), and mantle cell lymphoma. • • Alice Ma, MD University of North Carolina School of Medicine Chapel Hill, NC David Steensma, MD Dana-Farber Cancer Institute Boston, MA Keith Stewart, MBChB, MBA Mayo Clinic Scottsdale, AZ PUBLISHER American Medical Communications EDITORIAL approval to treat patients with CLL who carry a deletion in chromosome 17 (17p deletion) in July 2014. Ibrutinib received a breakthrough therapy designation for this use. Ibrutinib also received accelerated approval in November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. • Margaret V. Ragni, MD, MPH, discussed new longer-lasting fusion protein therapies, recombinant coagulation factor VIII (FVIII) Fc fusion protein for hemophilia A and recombinant coagulation factor IX (FIX) Fc fusion protein for hemophilia B. Each agent represents options for less-frequent dosing regimens by improving on the half-life of its non-fusion protein counterpart: 19 hours with rFVIIIFc (vs. 12.4 hours with rFVIII) and 82 hours with rFIXFc (vs. 33.8 hours with rFIX). Mitchell Smith, MD, PhD, discussed ibrutinib which received expanded Steven Coutre, MD, discussed idelalisib which was approved in July 2014 for the treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL), relapsed small lymphocytic lymphoma (SLL), and relapsed CLL, in combination with rituximab. Each speaker focused on the issues clinicians face in treating patients with the new drugs, including: appropriate population, dosing, side effects, adverse events, drug/ drug interactions, and off-label use. This supplement features clinical research updates on each of these newly approved drugs, as well as hematologic drugs coming down the pipeline. MANAGING EDITORS Ariel Jones, AMC Karen Learner, ASH ART DIRECTOR Ari Mihos ASSISTANT ART DIRECTOR Charlene DePrizio DIGITAL PROJECTS MANAGER Chris Gedikli ADVERTISING ACCOUNT MANAGER Nick Luciano [email protected] Gene Conselyea [email protected] Recruitment advertising orders can be sent to: DIRECTOR, RECRUITMENT CLASSIFIEDS John Baltazar, CSMR [email protected] ©2015 by the American Society of Hematology. All materials contained in this newsletter are protected by copyright laws and may not be used, reproduced, or otherwise exploited in any manner without the express prior written permission of ASH Clinical News. Any third-party materials communicated to ASH Clinical News become its copyrighted property and may be used, reproduced, or otherwise exploited by ASH Clinical News. ASHClinicalNews.org CONTENTS FEATURES 2 Bleeding Disorders 5 Lymphoma 8 Leukemia 15 Myeloma Subscription inquiries should be sent to: [email protected] All correspondence for the American Society of Hematology should be sent to: American Society of Hematology, 2021 L Street NW, Suite 900, Washington DC 20036. Neither the American Society of Hematology nor the publisher is responsible for statements made by any contributor. Statements or opinions expressed in ASH Clinical News magazine do not represent official policy of the American Society of Hematology unless so stated. No responsibility is assumed by the American Society of Hematology or the Publisher for any injury or damage to persons or property as a matter of product  liability, negligence or otherwise or from any use or operation of any methods, products, instructions or ideas contained in the material herein.  Although all advertising material published in ASH Clinical News magazine is expected to conform to ethical (medical) standards, inclusion in this publication does not constitute a guarantee or endorsement by the American Society of Hematology or the Publisher of the quality or value of such product or of the claim made of it by its manufacturer. About the American Society of Hematology The American S