MedicalNewsToday (KC) 25-Sep-08
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Life-Extending Kidney Cancer Drug Commended For Health Benefit And Innovation
Torisel ® (temsirolimus), Wyeth's innovative new treatment for poor prognosis advanced renal cell (kidney) cancer, has been commended at the 2008 UK Prix Galien. The commendation was made in the Prix Galien's new 'orphan drug' category, introduced this year for the first time to recognise advances in treating rarer diseases.
The Prix Galien is the pharmaceutical industry's premier award designed to recognise pharmaceutical innovation and the resulting health benefits it produces. The 2008 Prix Galien awards were made last night by Professor Sir Michael Rawlins, Chairman of the National Institute for Health and Clinical Excellence (NICE), who heads the Prix Galien judging panel.
Torisel is used to treat a subset of patients with advanced renal cell cancer who have the bleakest outlook, often termed poor prognosis.
Wyeth's temsirolimus (Torisel), the product of many years' investment in terms of research and development, is the first treatment for poor prognosis advanced renal cell cancer to significantly extend patients' overall survival versus the standard existing therapy, interferon-alpha.1 In a clinical study, overall patient survival increased by almost half from 7.3 months to 10.9 months.1 There are approximately 450 patients in the UK with poor prognosis advanced renal cell cancer who would be eligible for treatment with Torisel.
"Wyeth is honoured to receive this commendation and in particular I would like to acknowledge all those involved in its development including the scientists, clinicians, patients and their carers, "said Dr Vignesh Rajah, Wyeth's Medical Director in the UK. "Torisel represents an important advance in treating patients diagnosed with poor prognosis advanced renal cell cancer. These patients have a bleak outlook so Torisel is vitally important to them in offering them the opportunity for increased life-expectancy and the chance to enjoy valuable time with loved ones."
Dr Rajah added: "Disappointingly, despite receiving this recognition at Prix Galien, Torisel may not be available to patients in the UK. NICE's recent draft guidance on the use of Torisel and other new kidney cancer drugs, if implemented, will mean these new treatments will not be recommended for use by the NHS."
"Nevertheless, I am hopeful that this commendation will add weight to the argument that it is unfair and inequitable to deny patients treatment with Torisel if appropriate, and that NICE should reconsider its draft guidance on the use of Torisel and these other drugs by the NHS."
About the Prix Galien
The Prix Galien recognises the pharmaceutical industry's outstanding achievement in the development of new medicines. An internationally recognised award, the Prix Galien was founded in France in 1969 by French pharmacist Roland Mehl and adopted by other countries including the UK. The Prix Galien is named after the ancient Roman philosopher and teacher Claudius Galenus (AD 131-201) who is generally recognised as the 'father of modern pharmacology'.
About TORISEL
TORISEL is the first and only renal cell cancer therapy proven to extend overall survival in the treatment of advanced RCC in patients with poor prognosis compared with interferon-alpha.1 An open-label, randomised, phase 3 study compared TORISEL alone, a combination of TORISEL plus interferon-alpha, and interferon-alpha alone as first-line therapy in 626 patients with advanced RCC who had at least three of six prognostic risk factors.1
In this study, TORISEL alone significantly increased median overall survival by 49 % compared with interferon-alpha alone (10.9 months for TORISEL vs. 7.3 months for interferon-alpha, P=0.0078).2 TORISEL was also associated with statistically significant improvement over interferon-alpha in the secondary end point of progression-free survival (PFS), when the disease does not get worse (3.8 months of PFS vs. 1.9 months of PFS, P<0.001).2
TORISEL was granted a marketing authorisation for the EU on 19th November 2007 by the European Commission. TORISEL is indicated for the first-line treatment of patients with advanced renal cell carcinoma who have at least three of six prognostic risk factors.3
Orphan medicines
Orphan drugs are medicines used to treat rare or so-called 'orphan' conditions. In the EU, these are categorised as conditions affecting less than 5 per 10,000 individuals.
A further category - 'ultra orphan' drugs - are medicines used to treat conditions with a prevalence of less than 1 in 50,0004. Torisel therefore fulfils the condition to be designated an 'ultra orphan' drug.
About Wyeth Pharmaceuticals
References
1. Hudes, G., Carducci M., Tomczak P. et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007; 356: 2271-228 2. Data on file. Wyeth Pharmaceuticals CSR 64508 3. TORISEL UK SmPC Nov 2007. 4. NICE. Appraising Orphan Drugs 16 March 2006. Available here. Accessed September 2008.
View drug information on Torisel.
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