NICE Approves One Out Of The Four Specialised Medicines For Kidney Cancer (RCC) Patients, UK

February 5, 2009 at 11:00 am Leave a comment

In August 2008, the National Institute for Health and Clinical Excellence (NICE) issued its Appraisal Consultation Document (ACD) for the four kidney cancer drugs Nexavar® (sorafenib), Sutent® (sunitinib), Avastin® (bevacizumab) and Torisel® (temsirolimus), ruling that these treatments are not recommended for use in the NHS. NICE has today announced a part u-turn of its ACD, in that it has recommended only one of the four specialised medicines for treatment of a sub group of renal cell carcinoma (RCC) patients. A consultation process (due to report in March 2009), will consider all four medicines in a wider group of RCC patients.

Doctors have today been reported1 as saying that this decision by NICE has left them with few options to treat the 1,700 people diagnosed every year with the advanced form of the disease1. Whilst welcome, it is stressed that there are some patients who are not suited to sunitinib and who would do better on one of the other three medicines. “Sorafenib may be appropriate for selected patients;” said Professor Tim Eisen, a leading kidney cancer specialist at the University of Cambridge. And patient groups are calling on NICE to decide on the remaining three drugs as quickly as possible to ensure one or more is made available to patients.

Earlier this month, the Welsh Health Minister Edwina Hart announced that all four kidney cancer drugs would be made available to people in Wales.

Bayer Schering Pharma, manufacturer of Nexavar (sorafenib), makes this statement:

“Bayer Schering Pharma welcomes any guidance that ensures patients with RCC have the chance to access life prolonging medication. For those that can benefit from sunitinib, this is a step forward. Unfortunately, not all RCC patients will be able to benefit from this treatment or be suitable to try it in the first instance” said Nicole Farmer, Business Unit Head of Bayer Schering Pharma Oncology in the UK. She added: “NICE have recognised that Nexavar is a clinically effective2 life-extending end-of-life treatment3 with robust evidence in its support and we will continue to work closely with NICE and the Department of Health regarding access to Nexavar. It is widely accepted that allowing healthcare professionals greater access to a fuller range of treatment options for RCC patients, will make them better able to tailor treatment decisions to each patient individually. The patient, ultimately, benefits”

NICE RCC Decision

NICE have today issued 2 separate documents. A FAD recommending sunitinib as a first line option for patients with advanced/metastatic RCC patients who are suitable for immunotherapy and have an ECOG status of 0 or 1 and a ACD declining the use of bevacizumab, sorafenib and temsirolimus as first line and sorafenib and sunitinib as second-line treatment options for patients with RCC

About sorafenib for kidney cancer

Sorafenib was first approved by the EMEA in July 2006. Sorafenib is approved in the UK for the treatment of patients with advanced renal cell carcinoma (the most common form of kidney cancer), who have failed prior interleukin-2 or interferon-alpha based therapy, or are considered unsuitable for such therapy. Prior to EMEA approval of sorafenib, there had not been any new classes of licensed kidney cancer treatment in Europe for over 10 years.

Sorafenib’s differentiated mechanism

Sorafenib targets both the tumour cell and tumour vasculature. In preclinical studies, sorafenib has been shown to target kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-2, VEGFR-3, PDGFR-B, c-KIT, FLT-3 and RET5. Preclinical models have also demonstrated that the Raf/MEK/ERK pathway has a role in HCC5.

Bayer Schering Pharma

Bayer Schering Pharma is a leading, worldwide speciality pharmaceutical company. Its research and business activities are focussed on the fields of oncology, haematology & cardiology, diagnostic imaging, primary care, specialised therapeutics and women’s healthcare. With innovative products and using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life of patients – a factor of particular importance in Oncology.

Bayer Schering Pharma’s portfolio of oncological products includes treatments for both solid and haematological malignancies. Intensive research is ongoing as Bayer Schering Pharma strives to discover and advance therapeutic solutions for the benefit of all cancer patients.

For more information, please visit

Nexavar® (sorafenib) tablets is a registered trademark of Bayer Pharmaceuticals Corporation.


1. Kidney cancer drug gets go-ahead; BBC News

2. Appraisal consultation document – Bevacizumab, sorafenib, sunitinib (second line) and temsirolimus for the treatment of advanced and/or metastatic renal cell carcinoma, section 4.3.18.

3. Appraisal consultation document – Bevacizumab, sorafenib, sunitinib (second line) and temsirolimus for the treatment of advanced and/or metastatic renal cell carcinoma, section 4.3.20.

4. Nexavar (sorafenib) Summary of Product Characteristics, Bayer HealthCare AG, 2007.

5. Liu, L, Y. Cao, et al. Cancer Res, 2006; 66(24):11851-8

Bayer Schering Pharma’s



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