Navigation Links
New Meta-Analysis Confirms Safety Profile for NeoRecormon in Treating Anaemia in Cancer Patients
Date:6/10/2008

BASEL, Switzerland, June 11 /PRNewswire-FirstCall/ --

- Data Published in the British Journal of Cancer Reports That NeoRecormon use has no Negative Impact on Overall Survival or Tumour Progression

A new meta-analysis of all 12 prospective, randomised, controlled studies in 2,301 cancer patients shows that treating anaemia with NeoRecormon(R) (epoetin beta) has no negative impact on survival, tumour progression or deaths caused by blood clots, when used within its approved indications (1).

These encouraging results reported in the British Journal of Cancer, June 2008, showed no new safety concerns with NeoRecormon when used in accordance with its label and current EORTC guidelines.

Key findings of the meta-analysis

- No statistically significant difference in terms of overall survival

between patients receiving NeoRecormon or control.

- No statistically significant difference in disease progression between

NeoRecormon and the control groups, however there was a trend in favour

of a reduced risk of disease progression among NeoRecormon-treated

patients.

- There was an increased incidence of thromboembolic events (TEE) in the

NeoRecormon group (7.1% vs. 4.4%). This is consistent with the risk

observed in the erythropoiesis stimulating agent (ESA) class in

general, known by Health Authorities and described in all ESA labels.

There was no difference in the incidence of serious (4% vs. 3%) or

fatal TEEs (1% vs. 1%) for the NeoRecormon and control groups

respectively.

About the meta-analysis

- The meta-analysis was conducted to evaluate differences between

NeoRecormon and control (placebo or standard care) with regard to

overall survival, disease progression and TEEs.

- In contrast to other conventional meta-analyses, in this meta-analysis

individual patient level data and not study level data were used, which

allowed the conduct of more robust overall analysis and sub-analyses of

groups of special interest, such as those with haemoglobin (Hb) less#

than 11 g/dL.

- It included all 12 prospective, randomised, controlled studies in which

NeoRecormon was compared to placebo or standard treatment

(transfusions, if required) in patients with cancer undergoing

treatment with chemotherapy (7 studies), surgery (2 studies),

radiotherapy (2 studies) or radio-chemotherapy (1 study).

Since NeoRecormon was introduced nearly two decades ago, it has had an established safety and efficacy track record. Studies have confirmed that within its approved licence NeoRecormon has been shown to reduce the need for blood transfusions and to significantly improve quality of life for anaemic patients with cancer being treated with chemotherapy (2)(3)(4).

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Additional information about the Roche Group is available on the Internet at http://www.roche.com.

References

(1) Br J Cancer advance online publication 10 June 2008;

doi:10.1038/sj.bjc.6604408

(2) Br J Cancer. 2003 Apr 7;88(7):988-95

(3) Cancer Chemother Pharmacol. 2007 Jan;59(1):35-42

(4) J Clin Oncol. 2002 May 15;20(10):2486-94


'/>"/>
SOURCE Roche
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. New Data From Head-to-Head Study Confirms Once-Daily Levemir(R) is as Effective as Glargine over a 24-Hour Period in Subjects with Type 2 Diabetes
2. University of Miami Team Confirms Value of Monitoring Cell-Mediated Immunity Pre- and Post-Transplant in Management of Kidney Transplant Recipients
3. Study Confirms That Avastin Significantly Increases Chance of Living Without Disease Progression in Metastatic Breast Cancer
4. AviaraDx Confirms That Combination of Two Molecular Biomarkers Improves Prediction of Disease Recurrence in Early Stage Breast Cancer Patients
5. New Study Confirms Dose-Accuracy of SoloSTAR(R) Prefilled Insulin Pen
6. Interim Analysis of Phase I/II Study of Rexin-G Confirms Efficacy With No Dose Limiting Toxicity in Metastatic Pancreatic Cancer
7. FDA Confirms Seizure of Eyelash Product Was Not Prompted by Reports of Adverse Effects
8. New Data Confirms That a Selective, Fully Human Anti-VEGF Antibody Being Developed by Peregrine is as Effective as Avastin(R) in Preclinical Cancer Models
9. Study Confirms That New Protocol Shortens the Time It Takes to Open Blocked Arteries for Heart Attack Patients
10. IDM Pharma Announces Updated Phase 3 Mifamurtide (L-MTP-PE) Data Confirms Statistically Superior Overall Survival in Osteosarcoma Patients
11. Study Confirms Limited Human-To-Human Spread of Avian-Flu Virus in Indonesia in 2006
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... SAN FRANCISCO, Calif. , June 24, 2016 ... GBT ), a biopharmaceutical company developing novel therapeutics ... significant unmet needs, today announced the closing of ... shares of common stock, at the public offering ... shares in the offering were offered by GBT. ...
(Date:6/24/2016)... 24, 2016 ... the addition of the " Global Markets for ... This report focuses on ... updated review, including its applications in various applications. The ... which includes three main industries: pharmaceutical and biotechnology, food ...
(Date:6/24/2016)... The Academy of Managed Care Pharmacy (AMCP) ... would allow biopharmaceutical companies to more easily share health ... and coverage decisions, a move that addresses the growing ... The recommendations address restrictions in the sharing of ... label, a prohibition that hinders decision makers from accessing ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... 2016 , ... TherapySites, the leading website and ... Tennessee Counseling Association. This new relationship allows TherapySites to continue to extend ... exclusive benefits and promotional offers. , "TCA is extremely excited about this new ...
(Date:6/27/2016)... , ... June 27, 2016 , ... ... edge technology to revolutionize the emergency ambulance transport experience for the millions of ... of how Uber has disrupted the taxi industry through the use of technology. ...
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer care, ... remain in the eye of the beholder, according to experts who offered insights and ... Journal of Managed Care. For the full issue, click here . , For ...
(Date:6/26/2016)... ... ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect Plugin ... whole new perspective by using the title layers in ProSlice Levels to split-up ... Levels contains over 30 Different presets to choose from. FCPX users can ...
(Date:6/26/2016)... ... ... legally blind and certified personal trainer is helping to develop a weight loss fitness plan ... fix the two major problems leading the fitness industry today:, , ... They don’t eliminate all the reasons people quit their exercise program ...
Breaking Medicine News(10 mins):