Literature DB >> 20856755

Continued regulatory actions affecting the use of erythropoiesis-stimulating agents.

Karen Hagerty.   

Abstract

The FDA sent a "Complete Response and Safety Labeling Change Order" to the sponsors of ESAs on July 30, ordering changes to ESA labels in three important ways. For the first time, the FDA used its statutory authority to order a sponsor to make revisions to a product label.

Year:  2008        PMID： 20856755      PMCID： PMC2793911          DOI： 10.1200/JOP.0863501

Source DB:  PubMed          Journal:  J Oncol Pract        ISSN： 1554-7477            Impact factor:   3.840


  1 in total

1.  Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update.

Authors:  J Douglas Rizzo; Mark R Somerfield; Karen L Hagerty; Jerome Seidenfeld; Julia Bohlius; Charles L Bennett; David F Cella; Benjamin Djulbegovic; Matthew J Goode; Ann A Jakubowski; Mark U Rarick; David H Regan; Alan E Lichtin
Journal:  J Clin Oncol       Date:  2007-10-22       Impact factor: 44.544
  1 in total
  5 in total

1.  Trends in anemia treatment among patients with five non-myeloid malignancies treated with chemotherapy in a large integrated health care delivery system in California, 2000-2013.

Authors:  Lanfang Xu; Hairong Xu; Kimberly Cannavale; Olivia Sattayapiwat; Roberto Rodriguez; John H Page; Chun Chao
Journal:  Support Care Cancer       Date:  2016-02-12       Impact factor: 3.603

2.  Impact of safety concerns and regulatory changes on the usage of erythropoiesis-stimulating agents and RBC transfusions.

Authors:  Saroj Vadhan-Raj; Xiao Zhou; Kurt Sizer; Lincy Lal; Xuemei Wang; Joyce Roquemore; Weiming Shi; Robert S Benjamin; Benjamin Lichtiger
Journal:  Oncologist       Date:  2010-12-15

3.  Epidemiology of Chemotherapy-Induced Anemia in Patients with Non-Hodgkin Lymphoma.

Authors:  Kim Cannavale; Hairong Xu; Lanfang Xu; Olivia Sattayapiwat; Roberto Rodriguez; Chet Bohac; John Page; Chun Chao
Journal:  Perm J       Date:  2019-06-27

Review 4.  Pathogenesis and Treatment Options of Cancer Related Anemia: Perspective for a Targeted Mechanism-Based Approach.

Authors:  Clelia Madeddu; Giulia Gramignano; Giorgio Astara; Roberto Demontis; Elisabetta Sanna; Vinicio Atzeni; Antonio Macciò
Journal:  Front Physiol       Date:  2018-09-20       Impact factor: 4.566

Review 5.  Erythropoiesis-Stimulating Agents in the Management of Anemia in Chronic Kidney Disease or Cancer: A Historical Perspective.

Authors:  Matti Aapro; Pere Gascón; Kashyap Patel; George M Rodgers; Selwyn Fung; Luiz H Arantes; Jay Wish
Journal:  Front Pharmacol       Date:  2019-01-09       Impact factor: 5.810
  5 in total

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