GUILDFORD, England, September 30, 2011 /PRNewswire/ --
The National Institute for Health and Clinical Excellence (NICE) today issued the Appraisal Consultation Document (ACD) on JEVTANA (cabazitaxel). JEVTANA was approved by the European Commission for the treatment of men with metastatic, hormone-refractory prostate cancer (mHRPC) previously treated with docetaxel, in May 2011.
JEVTANA is the first of recently licensed drugs for the treatment of mHRPC to significantly extend overall survival in men whose disease has progressed during or after treatment containing docetaxel (15.1 months median overall survival vs. 12.7 months in the control arm; HR=0.70 (95% CI; 0.59-0.83); P<0.0001). Men with this stage of cancer typically have a poor prognosis and until recently there have been no licensed treatments available to extend life. JEVTANA represents a significant therapeutic advance in this regard.
Sanofi welcomes NICE's recognition of the significant clinical benefit JEVTANAoffers patients with mHRPC, but is disappointed that the Appraisal Committee's preliminary finding is not to recommend the use of JEVTANA on the basis of cost. NICE also expressed concerns over uncertainty in the cardiac and renal effects of JEVTANA. The effects of JEVTANA on the cardiac and renal systems have been explored thoroughly with the regulators, who assess all aspects of drug safety. This will be reiterated through the consultation process.
Dr Tony Whitehead, Medical Director, Sanofi comments: "JEVTANA is licensed in the UK for the treatment of men with metastatic, hormone-refractory prostate cancer and has been thoroughly reviewed and approved by the regulatory bodies. For this group of prostate cancer patients, JEVTANA offers an important new treatment option with significant clinical benefit."
There is significant clinical need within the NHS for JEVTANA - with around 80 patients having been prescribed the drug through the Cancer Drugs Fund (CDF) in the last 3 months. JEVTANA is currently available to patients in 9 out of 10 Strategic Health Authorities in England through the CDF.
The consultation document does not constitute NICE's formal guidance on this technology, which should be issued in a few months. It represents a first step in the process and their preliminary thoughts, and may change after further consultation. Sanofi is committed to working with NICE throughout this ongoing consultation period to assist in the development of the final recommendation and to achieve the best possible outcome for men with mHRPC.
- De Bono JS, Oudard S, Ozguroglu M et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomized open-label trial. Lancet 2010;376:1147-54
- National Institute for Health and Clinical Excellence. Docetaxel for the treatment of hormone-refractory metastatic prostate cancer. Technology Appraisal 101. London: NICE, 2006
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Date of Preparation: September 2011