Navigation Links
Statement by US Oncology on FDA Label on Erythropoiesis Stimulating Agents (ESAs)

HOUSTON, Nov. 8 /PRNewswire-USNewswire/ -- US Oncology, who supports one of the nation's largest cancer treatment and research networks representing over 1,100 oncologists nationwide, supports the FDA's label outlining the safe and effective administration of ESAs at the minimum level of the range 10-12 grams per deciliter (gm/dL), a declaration that has long been a central part of the US Oncology physician network's recommended clinical guidelines.

Recently, a number of health concerns have arisen for ESA dosing levels exceeding 12 gm/dL. The FDA's new label repeatedly notes the upper safety limit is 12 gm/dL, and preserves physician discretion to use the lowest dose possible in order to avoid blood transfusions - widely regarded as cumbersome for patients and carry several health risks -- and to continue treatment within the range of 10-12 gm/dL.

Physician discretion remains the critical point of debate. The current FDA labeling provides flexibility for patients and physicians to decide whether the use of ESAs is appropriate for each individual case. These considerations may include the type and anticipated duration of chemotherapy and its known impact on blood cell reproduction.

The new FDA label supports anemia management protocols adopted by US Oncology, the American Society of Hematology (ASH), the American Society of Clinical Oncology (ASCO), the European Agency for the Evaluation of Medicinal Products (EMEA), and all major U.S. health insurance plans. All of these groups support the same physician-centric approach and reflect a target range of 10 gm/dL and 12 gm/dL. This treatment range stands in contrast only to the National Coverage Determination (NCD) recently adopted by the Centers for Medicare and Medicaid Services (CMS), which denies coverage for ESAs above the hemoglobin levels of 10 gm/dL.

US Oncology and its affiliated network of physicians continue to be concerned that the NCD interferences with medically-evidenced treatment protocols for cancer patients and creates a two-tiered health care system based on insurance -- one for patients with Medicare and one for patients with private insurance. Under the new CMS NCD policy, Medicare beneficiaries risk reaching hemoglobin levels oncologists regard as inappropriately low for health a safety, and as a result, will risk blood transfusion.

One new warning in the FDA label states, "the risks of shortened survival and tumor promotion have not been excluded when ESAs are dosed to target a hemoglobin of < 12 gm/dL." While US Oncology agrees with the accuracy of this statement, numerous clinical trials looking at adverse events in the 10-12 gm/dL range have found no evidence of reduced mortality or tumor progression.

Given this new label, US Oncology maintains that patients should continue to review the risks and benefits of the most safe and effective anemia management protocol with their physician while undergoing chemotherapy to treat their individual disease.

SOURCE US Oncology
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients
2. Statement From The National Conclave on HIV/AIDS Policy for Black Clergy
3. Paper in International Journal of Oncology Reports Alfacells ONCONASE(R) Suppresses Intracellular Oxidative Stress
4. HistoRx and Radiation Therapy Oncology Group Initiate Brain Tumor Biomarker Research Partnership
5. Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
6. Oncology Drugs Development Update - Worldwide Markets and Forecasts of Approved EGFr/HEr2 Inhibitors, Treatment Costs, Pathway Analysis, Current and Expanded Clinical Indications, and Novel Agents in Development
7. Strategic Diagnostics Launches Initial Oncology-Targeted Antibody Reagent Catalog
8. University of Pennsylvania School of Medicine Study Shows Significant Differences in English- and Spanish-speakers Use of Oncology Websites
9. Ortho Biotech Reiterates Confidence in PROCRIT(R) (Epoetin alfa) Safety and Efficacy When Used According to Label
10. Proteolix Initiates Multicenter Open-label Study of the Safety and Activity of Carfilzomib in Subjects With Relapsed Solid Tumors
11. Advanced Life Sciences Collaborates with U.S. Government to Study Cethromycin as Treatment for Anthrax and Other High-Priority Biodefense Agents
Post Your Comments:
(Date:11/25/2015)... , Nov. 25, 2015  Linden Care, LLC, ... optimizing treatment outcomes for patients suffering from chronic pain, ... for a Temporary Restraining Order (TRO) enjoining Express Scripts ... two companies. --> --> ... all of its legal options. --> ...
(Date:11/25/2015)... AVIV, Israel , November 25, 2015 ... (NASDAQ: KTOV ) (TASE: KTOV), a biopharmaceutical company ... simultaneous treatment of various clinical conditions, today announced the ... 3,158,900 American Depository Shares ( ADSs ), each representing ... purchase up to 3,158,900 ADSs. The ADSs and warrants ...
(Date:11/25/2015)... DUBLIN , Nov. 25, 2015 Endo International ... Rajiv De Silva , President and CEO, will discuss ... Healthcare Conference in New York on ... . Click on Investor Relations, and then the ... prior to the presentation,s start time to visit the site ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... Beddit® has launched a new Android app ... new app features a more intuitive SleepScore™ that rates sleep quality on a 100-point ... SleepScore is created by a proprietary algorithm. Beddit analyzes the data to provide an ...
(Date:11/25/2015)... ... November 25, 2015 , ... In an ongoing Clinical ... Center (RMC) in Chicago, IL, UV Angel is evaluating the efficacy of its product ... intensive care units (totaling 30 beds) from May 2014 through October 2015 at a ...
(Date:11/25/2015)... ... , ... Today, Mothers Against Drunk Driving (MADD) learned that the ... the first time since 2011. In 2014, there were 9,967 fatalities involving an alcohol ... National Highway Traffic Safety Administration (NHTSA), 32,675 people were killed in traffic crashes in ...
(Date:11/25/2015)... ... November 25, 2015 , ... In ... nation’s Periwinkle Pioneers, individuals and groups responsible for advancing care for pulmonary hypertension ... Pioneers, nominated by the public, will receive special recognition throughout 2016 as part ...
(Date:11/25/2015)... ... November 25, 2015 , ... Privately owned Contract Development ... expansion of its current state of the art research, development and manufacturing facility ... increase its manufacturing capacity as well as to support its clients’ growing research ...
Breaking Medicine News(10 mins):