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New Meta-Analysis Confirms Safety Profile for NeoRecormon in Treating Anaemia in Cancer Patients

Wednesday, June 11, 2008 General News J E 4
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BASEL, Switzerland, June 11

- Data Published in the British Journal of Cancer Reports ThatNeoRecormon use has no Negative Impact on Overall Survival or TumourProgression

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

These encouraging results reported in the British Journal of Cancer, June2008, showed no new safety concerns with NeoRecormon when used in accordancewith its label and current EORTC guidelines.

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

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leadingresearch-focused healthcare groups in the fields of pharmaceuticals anddiagnostics. As the world's biggest biotech company and an innovator ofproducts and services for the early detection, prevention, diagnosis andtreatment of diseases, the Group contributes on a broad range of fronts toimproving people's health and quality of life. Additional information aboutthe Roche Group is available on the Internet at http://www.roche.com.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).

SOURCE Roche
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