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Marina Bacac, Sara Colombetti, Sylvia Herter, Johannes Sam, Mario Perro, Stanford Chen, Roberta Bianchi, Sarah Diggelmann, Florian Limani, Ramona Schlenker, Tamara Hüsser, Wolfgang F Richter, Katharine Bray-French, Heather J Hinton, Anna Maria F Giusti, Anne Freimoser-Grundschober, Laurent Larivière, Christiane Neumann, Christian Klein, Pablo Umana
PURPOSE: Despite promising clinical activity, T cell engaging therapies including T cell bispecific antibodies (TCBs) are associated with severe side effects requiring the use of step-up-dosing (SUD) regimens to mitigate safety. Here, we present a next generation CD20-targeting TCB (CD20-TCB) with significantly higher potency and a novel approach enabling safer administration of such potent drug. EXPERIMENTAL DESIGN: We developed CD20-TCB based on the 2:1 TCB molecular format and characterized its activity pre-clinically...
May 1, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Troy Z Horvat, Amanda N Seddon, Adebayo Ogunniyi, Amber C King, Larry W Buie, Ryan J Daley
OBJECTIVE: To review the pharmacology, efficacy, and safety of Food and Drug Administration approved and promising immunotherapy agents used in the treatment of acute lymphoblastic leukemia (ALL). DATA SOURCES: A literature search was performed of PubMed and MEDLINE databases (1950 to July 2017) and of abstracts from the American Society of Hematology and the American Society of Clinical Oncology. Searches were performed utilizing the following key terms: rituximab, blinatumomab, inotuzumab, ofatumumab, obinutuzumab, Blincyto, Rituxan, Gazyva, Arzerra, CAR T-cell, and chimeric antigen receptor (CAR)...
March 2018: Annals of Pharmacotherapy
Elisabeth Husar, Maria Solonets, Olaf Kuhlmann, Eginhard Schick, Hanna Piper-Lepoutre, Thomas Singer, Gaurav Tyagi
Obinutuzumab (GA101, Gazyva™, Gazyvaro®, F. Hoffmann-La Roche AG, Basel, Switzerland) is a humanized, glycoengineered type II antibody targeted against CD20. The preclinical safety evaluation required to support clinical development and marketing authorization of obinutuzumab included repeat-dose toxicity studies in cynomolgus monkeys for up to 6-month dosing with a 9-month recovery period. Results from those studies showed decreases in circulating B cells and corresponding B-cell depletion in lymphoid tissues, consistent with the desired pharmacology of obinutuzumab...
July 2017: Toxicologic Pathology
Sohita Dhillon
Obinutuzumab (Gazyva® , Gazyvaro® ) is a recombinant, monoclonal, humanized and glycoengineered, type II, anti-CD20, IgG1 antibody. It has recently been granted an additional indication for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen. In the primary analysis of the large, phase III GADOLIN study, induction therapy with obinutuzumab plus bendamustine followed by obinutuzumab maintenance prolonged progression-free survival (PFS) to a statistically significant extent relative to induction with bendamustine monotherapy in patients with indolent non-Hodgkin's lymphoma (iNHL)...
April 2017: Targeted Oncology
Wei Wen Chien, Charlène Niogret, Romain Jugé, Loïc Lionnard, Aurélie Cornut-Thibaut, Jérôme Kucharczak, Ariel Savina, Gilles Salles, Abdel Aouacheria
GA101, also known as obinutuzumab or Gazyva (Gazyvaro), is a glycoengineered type II humanized antibody that targets the CD20 antigen expressed at the surface of B-cells. This novel anti-CD20 antibody is currently assessed in clinical trials with promising results as a single agent or as part of therapeutic combinations for the treatment of B-cell malignancies. Detailed understanding of the mechanisms of GA101-induced cell death is needed to get insight into possible resistance mechanisms occurring in patients...
April 2017: Leukemia Research
Keith Dawson, Mollie Moran, Kathleen Guindon, Hui Wan
BACKGROUND: In patients with previously untreated chronic lymphocytic leukemia (CLL) and comorbidities, treatment with the glycoengineered, type II anti-CD20 monoclonal antibody obinutuzumab (Gazyva®) (GA101) plus chlorambucil (Leukeran®) was associated with superior outcomes to rituximab (Rituxan®) plus chlorambucil, with a similar safety profile. However, a higher occurrence of infusion-related reactions (IRRs) was reported with obinutuzumab. These reactions typically require additional management...
April 2016: Clinical Journal of Oncology Nursing
Sheridan M Hoy
Obinutuzumab (Gazyva(®); Gazyvaro(®)) is an intravenously administered, glycoengineered, humanized, type II, anti-CD20 monoclonal antibody of the IgG1 subclass. It is available in the EU and the USA as combination therapy with oral chlorambucil in adults with previously untreated chronic lymphocytic leukaemia (CLL). In a multinational phase III study in this patient population, obinutuzumab plus chlorambucil significantly prolonged progression-free survival compared with oral chlorambucil alone and intravenous rituximab plus oral chlorambucil...
February 2015: Drugs
(no author information available yet)
No abstract text is available yet for this article.
November 10, 2014: Medical Letter on Drugs and Therapeutics
Ashish Kumar Kakkar, Sadasivam Balakrishnan
Obinutuzumab (also known as GA101, afutuzumab, Gazyva) is a humanized, glycoengineered type II monoclonal antibody targeted against CD20. The US Food and Drug Administration has approved obinutuzumab for use with chlorambucil in patients with previously untreated chronic lymphocytic leukemia. The drug is the first treatment to receive approval under the agency's breakthrough therapy designation, a program intended to facilitate and expedite the review and development of therapies for serious and life-threatening conditions...
October 2015: Journal of Oncology Pharmacy Practice
Hyon-Zu Lee, Barry W Miller, Virginia E Kwitkowski, Stacey Ricci, Pedro DelValle, Haleh Saber, Joseph Grillo, Julie Bullock, Jeffry Florian, Nitin Mehrotra, Chia-Wen Ko, Lei Nie, Marjorie Shapiro, Mate Tolnay, Robert C Kane, Edvardas Kaminskas, Robert Justice, Ann T Farrell, Richard Pazdur
On November 1, 2013, the U.S. Food and Drug Administration (FDA) approved obinutuzumab (GAZYVA; Genentech, Inc.), a CD20-directed cytolytic antibody, for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). In stage 1 of the trial supporting approval, patients with previously untreated CD20-positive CLL were randomly allocated (2:2:1) to obinutuzumab + chlorambucil (GClb, n = 238), rituximab + chlorambucil (RClb, n = 233), or chlorambucil alone (Clb, n = 118)...
August 1, 2014: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Marvin M Goldenberg
Obinutuzumab (Gazyva) for chronic lymphocytic leukemia; ibrutinib (Imbruvica) for mantle-cell lymphoma; and sofosbuvir (Sovaldi) for chronic hepatitis C infection.
January 2014: P & T: a Peer-reviewed Journal for Formulary Management
Fiona Cameron, Paul L McCormack
Obinutuzumab (Gazyva™) is an intravenously administered, humanized and glycoengineered, type II anti-CD20 monoclonal antibody for the treatment of B-cell malignancies. It is approved in the US for use in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukaemia (CLL), and has been filed for approval in the EU in this indication. The antibody is based on GlycArt Biotechnology's (later Roche Glycart AG) proprietary GlycoMAb® technology, which uses glycoengineered antibodies that specifically increase antibody-dependent cellular cytotoxicity and thereby increase immune-mediated target cell death...
January 2014: Drugs
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