Press Release

Final NICE kidney cancer guidance recommends Sutent® (sunitinib) only
Published guidance will ensure door now open for NHS funding

London, Wednesday 25 March, 2009 – Today, the National Institute for Health and Clinical Excellence (NICE) has issued final guidance recommending the use of Sutent (sunitinib) for the first-line treatment of metastatic renal cell carcinoma (mRCC), commonly known as advanced kidney cancer. Sunitinib, the only oral treatment to show overall survival greater than two years in advanced kidney cancer patients, is one of four treatments which have been reviewed by NICE as part of a multiple technology appraisal. This decision reverses NICE’s earlier appraisal consultation document (ACD) issued in August 2008, which advised against the use of all four medicines for the treatment of mRCC. However, at a subsequent meeting of the appraisal committee, NICE took the decision to split the appraisal process, resulting in firstly, a recommendation for sunitinib and secondly a reappraisal of the other three treatments.

“I am delighted that Sutent will be available.” said Professor Robert Hawkins, Christie Hospital Manchester. “It will remove a great deal of anxiety and uncertainty for people diagnosed with renal cancer to know that modern, effective treatment is now available to them” he continued.

The appraisal committee recognised that sunitinib provides a step-change in the first-line treatment of advanced kidney cancer and has noted that more than 20% of the public and patients that responded in consultation highlighted the impressive benefit from sunitinib

New data for sunitinib have emerged since NICE began this appraisal process. Median overall survival for patients who received sunitinib vs interferon-alpha (IFN-α) was 26.4 months vs. 21.8 months respectively (p=0.051). However, an exploratory analysis of patients who received only one line of treatment (i.e. no subsequent treatments after stopping their sunitinib or IFN-α therapies) showed that sunitinib almost doubles the time it keeps patients alive compared to
IFN-α [28.1 months vs 14.1, HR = 0.647 (p=0.0033, log-rank]). This is a reflection of clinical practice in the UK where generally patients are only funded for one line of treatment at most.

It is estimated more than 7,000 people are diagnosed with kidney cancer in the UK each year and approximately 3,600 people die from the disease. Until recently, treatment options were limited to IFN-α, the current NHS funded standard of care.

James Whale, Chairman of the James Whale Fund for Kidney Cancer, expressed his delight on hearing the news, “Finally, we have justice for the kidney cancer community. This positive recommendation from NICE will allow thousands of kidney cancer patients in England and Wales access to this life-extending treatment. The options previously available to us have been limited and are inadequate for the majority of patients. For some, sunitinib is the only hope.”

Currently, over half of PCTs (primary care trusts) in England are already funding sunitinib to some extent for the treatment of mRCC. Across Western Europe eligible patients with advanced kidney cancer are routinely prescribed sunitinib, where it is now recognised as a standard of care.

Pat Hanlon, spokesperson for Kidney Cancer UK commented “After two and half years of campaigning we are delighted with this news and hope that PCTs will move quickly to implement the NICE guidance and ensure these deserving and distressed patients get access to a treatment that will allow them the chance of precious extra life.”

Rob Day, Director of Oncology UK, Pfizer Limited, commented, “We are truly delighted that NICE has taken the decision in its final guidance to enable UK patients to benefit from sunitinib, a medicine that has become a standard of care in the rest of the world. Not only will this decision have immediate benefits for eligible patients today, but will also pave the way for future treatment advances in kidney cancer. ”

Sunitinib, an oral medicine, received marketing authorisation in July 2006 and was approved as a first-line treatment for mRCC in January 2007. It is a novel addition to a new class of ‘multi-targeted’ anti-cancer drugs. It targets the tumour with a dual action approach, by stopping the cancer cells from multiplying and also cutting off the tumour’s blood supply.