Public HealthAfinitor(R) (everolimus) Recommended For Use In The European Union For Patients With Advanced Renal Cell Carcinoma
Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) supporting European Union (EU) approval of everolimus for the treatment of patients with advanced renal cell carcinoma (RCC)3, the most common type of kidney cancer4.
The CHMP has recommended approval of everolimus based on data demonstrating that when compared with placebo, everolimus more than doubled median progression free survival in patients with advanced kidney cancer (4.9 vs. 1.9 months), whose disease progressed on or after treatment with VEGF-targeted therapy. Additionally, the data showed everolimus reduced the risk of disease progression or death by 67% (hazard ratio=0.33 with 95% confidence interval 0.25 to 0.43; PFiling data
The EU regulatory filing for everolimus was based on data from RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily), the largest Phase III clinical trial to study the effects of an oral mTOR inhibitor in advanced RCC patients whose cancer progressed despite prior treatment. In February 2008, based on a recommendation from an independent data monitoring committee, Novartis stopped the trial after interim results showed that patients receiving everolimus experienced a significant delay in cancer progressing or death compared with patients receiving placebo1,5.
This international, multi-centre, randomised, double-blind trial involved 416 patients with advanced RCC whose cancer progressed despite prior treatment with sunitinib or sorafenib. In addition, prior therapy with bevacizumab, interferon alfa and interleukin-2 was allowed. Patients were randomised to receive Afinitor (10 mg) daily or placebo, in conjunction with best supportive care. The primary endpoint of the study was progression-free survival, which was assessed via a blinded independent, central radiological review1,5.
References
1 Motzer RJ, Escudier B, Oudard S et al for the RECORD-1 study group. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. The Lancet. August 2008; 372;9637:449-456
2 Novartis data on file AFT002
3 CHMP website http://www.emea.europa.eu/pdfs/human/press/pr/33058009en.pdf- Last accessed 1 June 2009
4 Novartis data on file AFT001
5 Escudier, B et al. 72O - Phase III Randomised Trial of Everolimus (RAD001) vs Placebo in Metastatic Renal Cell Carcinoma. Presented at the European Society for Medical Oncology (ESMO) 33rd Congress, Stockholm, Sweden on 16 September 2008.
6 FDA website http://www.fda.gov/bbs/topics/NEWS/2009/NEW01980.html - Last accessed 28 May 2009
7 McLaughlin JK, Lipworth L, Tarone RE. Epidemiological aspects of renal cell carcinoma. Semin Oncol. 2006 Oct;33(5):527-33. [Abstract]
8 Eisen, et al. Sorafenib for Older Patients With Renal Cell Carcinoma: Subset Analysis From a Randomized Trial. Journal of the National Cancer Institute. 2008; 100(20):1454-1463.
About RCC
Renal cell cancer accounts for 2% of all new cancer cases worldwide with occurrence rates rising steadily around the world7 due in part to smoking and obesity8.
In the UK, RCC has increased by 22% over the last ten years. Each year, approximately 6,600 people in the UK are diagnosed with kidney cancer, which also causes around 3,600 deaths each year. There are several types of RCC, but the most common, called clear cell, accounts for 80% of diagnoses. In RCC, cancer cells develop in the lining of the kidney"s tubes and grow into a tumour4.
About Afinitor
Afinitor is approved in the US as the first oral, daily therapy (5 mg and 10 mg tablets) to treat patients with advanced RCC after failure of treatment with sunitinib or sorafenib6. Afinitor works by directly targeting mTOR, a protein in the cancer cell that controls tumour cell division and blood vessel growth. Preclinical and clinical data have established the important role of mTOR in the development and progression of several types of tumours.
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