Sutent not approved for Patients with GIST

According to newly published guidance patients who suffer from a rare form of stomach cancer should not be prescribed Sutent, also known as sunitinib, on the NHS.

The National Institute for Health and Clinical Excellence (Nice) said patients with advanced gastrointestinal stromal tumour (GIST) should not be given the drug Sutent. The rare form of cancer affects the soft tissue surrounding the digestive tract and around 1,500 people in the UK are believed to be living with the advanced form of the cancer, which is terminal and between 700 and 900 new cases of the cancer are detected each year.

Nice had previously turned down the drug for use in patients with advanced kidney cancer, a decision that has been overturned following new rules on drugs for patients with rare conditions at the end of their lives.

In draft guidance Nice has refused to approve Sutent recommending the drug not be given as a second-line treatment for people with advanced GIST.

Dr Beatrice Seddon, consultant clinical oncologist at University College London Hospital said, "We have within our reach an effective treatment in sunitinib, which could benefit many GIST patients. Without positive guidance, our hands are tied and we will be forced to deny our patients the chance of extended good quality life."

Dr Seddon added that Sutent was a necessary option for patients who had stopped responding to another drug, Glivec (also known as imatinib). "This is a devastating blow to the GIST community," she said.

It is believed that Nice expressed uncertainty around the way clinical trial data was analysed in a submission from Sutent's manufacturer, Pfizer. According to Pfizer, Sutent has been shown to delay tumour progression by over five months, versus normal care, in patients who have stopped responding to Glivec.

Robert Day, director of UK oncology at Pfizer, said: "Clearly this is disappointing news for the GIST community, as it will prolong the struggle for many people with advanced GIST currently unable to access sunitinib.Pfizer is committed to working with Nice to reverse this initial guidance so that people with this deadly cancer will no longer have to battle to gain access to sunitinib."

A spokesman for Nice said, "Nice is currently appraising the use of sunitinib for the treatment of gastrointestinal stromal tumours (GIST).

"In its draft guidance Nice is minded not to recommend sunitinib, within its marketing authorisation, as a treatment option for people with unresectable and/or metastatic malignant GIST after failure of imatinib treatment because of resistance or intolerance. Nice has now asked the manufacture of sunitinib to provide Nice with additional data on the effectiveness of this treatment before the next independent advisory Committee meeting on 8 April 2009.

"In the meantime this draft guidance has been issued for consultation. Nice has not yet issued final guidance to the NHS."

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