NDLI: Obinutuzumab: a novel anti-CD20 monoclonal antibody for previously untreated chronic lymphocytic leukemia.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Shah, Arpita
Spatial Coverage	United States
Description	Country affiliation: United States Author Affiliation: Shah A ( Georgia Regents University Medical Center (formerly MCG Health), Augusta, GA, USA arshah@gru.edu.)
Abstract	OBJECTIVE: To review and summarize data on obinutuzumab, which was approved by the Food and Drug Administration (FDA) in November 2013 for use in combination with chlorambucil for previously untreated chronic lymphocytic leukemia (CLL). DATA SOURCES: A PubMed literature search (August 2002 to March 2014) was conducted using the terms obinutuzumab, GA101, anti-CD20 antibody, and CLL. Data were also obtained through the FDA briefing documents and American Society of Hematology abstracts. STUDY SELECTION AND DATA EXTRACTION: The literature search was limited to human studies published in English. Priority was placed on trials of obinutuzumab in previously untreated CLL. DATA SYNTHESIS: Obinutuzumab is a novel glycoengineered type II anti-CD20 monoclonal antibody, with a higher affinity for CD20 epitope, leading to superior cytotoxicity compared with rituximab. The FDA approval was based on a phase III, randomized trial of chlorambucil monotherapy (n = 118), chlorambucil plus obinutuzumab (n = 333), or rituximab (n =330) in previously untreated elderly CLL patients. Obinutuzumab was administered intravenously as 1000 mg on days 1, 8, and 15 of cycle 1 and day 1 for subsequent cycles. Median progression-free survival was 26.7 months in the chlorambucil plus obinutuzumab arm. The incidence of grade 3 or higher adverse events in the obinutuzumab plus chlorambucil arm was as follows: neutropenia (33%), infusion-related reactions (20%), thrombocytopenia (10%), and infections (7%). CONCLUSION: Obinutuzumab in combination with chlorambucil is a safe and effective new treatment option for previously untreated elderly CLL patients. It should become the new preferred therapy for these patients with significant comorbidities who are not candidates for fludarabine-based therapy.
File Format	HTM / HTML
ISSN	10600280
Issue Number	10
Volume Number	48
e-ISSN	15426270
Journal	Annals of Pharmacotherapy
Language	English
Publisher	SAGE Publications
Publisher Date	2014-10-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmaceutical Science Antibodies, Monoclonal, Humanized Therapeutic Use Antigens, Cd20 Immunology Antineoplastic Agents Leukemia, Lymphocytic, Chronic, B-cell Drug Therapy Administration & Dosage Antineoplastic Combined Chemotherapy Protocols Chlorambucil Disease-free Survival Humans United States United States Food And Drug Administration Journal Article Review
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

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