New Hope For Kidney Cancer Patients With HSA Approval Of Anticancer Drug Nexavar

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Urology / Nephrology;  Pharma Industry / Biotech Industry
Article Date: 31 Aug 2007 - 1:00 PDT

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Bayer Schering Pharma announced that the Singapore Health Sciences Authority (HSA) has approved Nexavar® (Sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma (ARCC), or advanced kidney cancer. Nexavar, the first oral treatment in Singapore indicated for ARCC, is a multi-targeted therapy which has been shown to double progression free survival, or the length of time that a patient lives without evident tumour growth or death, in patients with ARCC1.

"This new therapy directly targets the blood vessels that feed the tumours and tumour growth, to improve the quality of life for patients with advanced kidney cancer. For many years, toxic therapies such as interferon alfa or interleukin-2 have been the only available treatments for advanced kidney cancer, but they work for only a small percentage of patients. There has been a critical need for new therapies to help patients with advanced disease and we are delighted that kidney cancer patients in Singapore now have access to Nexavar," said Dr. Ang Peng Tiam, Medical Director, Senior Consultant Medical Oncologist, Parkway Cancer Centre, Mount Elizabeth Medical Centre.

"Nexavar represents a new treatment paradigm for kidney cancer patients who, until now, have had limited treatment options. In addition to targeting the blood vessels that feed the tumours, Nexavar also directly targets the cancer cells. The HSA approval of Nexavar is a crucial step for patients with advanced kidney cancer. Compared with current treatments for kidney cancer, which have been associated with undesirable side effects such as appetite loss and fever, and in some cases, patients have had to stop treatment completely; this new therapy has fewer and milder side effects. This translates to a better quality of life for patients. I had a patient who was battling advance kidney cancer and since being on Nexavar late last year on special approval by the HSA, he is now managing his condition well and enjoying simple things that many of us take for granted, such as driving and eating at hawker centres. Nexavar not only stopped his disease from progressing, but also shrank his tumours," said Dr Tay Miah Hiang, Consultant, Medical Oncology, OncoCare Cancer Centre, Gleneagles Medical Centre.

Kidney Cancer - A Deadly Disease in Singapore

Advanced kidney cancer is a deadly disease with a poor prognosis, with limited treatment options and low survival rates. According to the National Cancer Institute in the United States, the current estimated five-year survival rate for patients with advanced kidney cancer is less than 10 percent.

Globally, RCC is the most common form of kidney cancer. Nearly 208,000 people worldwide are diagnosed with renal cell carcinoma each year and more than 102,000 of them die from the disease annually2. In Singapore, from 1998 to 2002, there were 334 kidney cancer-related deaths3.

About Nexavar

In December 2005, the U.S Food and Drug Administration (FDA) approved Nexavar based on data from the largest ever randomized, placebo-controlled, international trial in patients with ARCC, in which 130 centres participated. The trial established that treatment with Nexavar resulted in approximately a doubling of progression-free-survival.

Nexavar is the first, oral multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumour cell and tumour vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both tumour cell proliferation (tumour growth) and tumour angiogenesis (tumour blood supply) - two important cancer growth activities.

These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-ß, KIT, and FLT-3.

Nexavar has been studied in more than 20 tumour types and more than 4,000 patients to date. It is currently approved in more than 50 countries, including the United States and those in the European Union, for the treatment of patients with RCC.

In Singapore, Nexavar is available by doctor's prescription from cancer centres and specialists oncologists.

Bayer Schering Pharma Singapore

Bayer Schering Pharma Singapore is a subsidiary of the German-based Bayer Schering Pharma AG. Bayer Schering Pharma AG, majority-owned by the Bayer Group, is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology, Primary Care, and Oncology. With innovative products, Bayer Schering Pharma AG aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma AG aims to make a contribution to medical progress and strives to improve the quality of life.

References

1 Escudier, B et al, 2007, 'Sorafenib in Advanced Clear-Cell Renal-Cell Carcinoma', The New England Journal of Medicine, 356:125-34

2 J. Ferlay, F. Bray, P. Pisani and D.M. Parkin. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide IARC CancerBase No. 5. version 2.0, IARCPress, Lyon, 2004

3 A. Seow, W.P. Koh, K.S. Chia, L.M. Shi, H.P. Lee, K. Shanmugaratnam. Singapore Cancer Registry Report No.6: Trends in Cancer Incidence in Singapore 1968 - 2002, Page 8

http://www.bayerscheringpharma.de