Decision next year on skin cancer drug

22^nd August 2011 - A decision on whether to approve the first new skin cancer treatment since the 1970s for use in the NHS is expected in the first quarter of next year. It follows a decision by European regulators to grant a marketing licence for ipilimumab.

The medication, which is marketed by Bristol-Myers Squibb under the brand name Yervoy, is used to treat advanced melanoma. It is given to adults for whom other treatment does not work or which has stopped working.

Melanoma

Melanoma - also known as malignant melanoma - is a rare type of skin cancer. It is serious because it can spread to other parts of the body - a process known as metastasis.

Although melanoma only makes up 10% of all skin cancer cases, it is responsible for most skin cancer deaths. Around 2,000 people die from melanoma each year in England and Wales.

Ipilimumab works by blocking the activity of a protein that inhibits the activity of T-cells. When the protein - known as CTLA-4 - has been stopped, the affected T-cells can spread, infiltrating and killing tumour cells that remain in the patient.

Injections

Treatment consists of four doses of the medication, given by a drip into a vein. The estimated cost of the four infusions has been put at around £75,000.

One study, which involved tests on 676 patients, found that ipilimumab improved survival rates. Participants, who had previously been treated for advanced melanoma, were either given ipilimumab, an experimental medicine called gp100, or both ipilimumab and gp100. The study found that patients survived for around 10 months on treatment with ipilimumab or the combination treatment, compared with six months on gp100 alone.

Last month the European Medicines Agency granted a marketing licence for the treatment. It said that ipilimumab had been shown to improve patients' survival in a condition where overall survival rates were low. It said that side effects from the medication were rated low to moderate. These include diarrhoea, rash, itching, fatigue, nausea and vomiting.

NHS decision pending

The decision by European regulators means that ipilimumab can be obtained in the UK. However, no decision has yet been taken on whether to approve the treatment for use on the NHS. The National Institute for Health and Clinical Excellence (NICE) is to hold a first appraisal meeting next month. A NICE spokeswoman tells us that final guidance on the treatment is expected in February 2012.

'Exciting': Cancer charity

"A diagnoses of metatastic melanoma is devastating," says Richard Clifford, trustee of the skin cancer charity SKCIN, who hopes that the cost of treating with ipilimumab will not prove prohibitive. "We waited for a long time for a new effective treatment to offer hope to some of these patients," he tells us.

Sarah Woolnough, Cancer Research UK’s director of policy, says in a statement: "It’s exciting that Ipilimumab is now licensed for use in the UK, as this means it is one step closer to becoming available for patients with melanoma - the most dangerous form of skin cancer.

"This is one of the first effective treatments we have for advanced melanoma and it’s important that NICE makes a decision as quickly as possible on whether or not the drug should be made routinely available to all appropriate patients. In the meantime decisions about whether patients can get this drug will have to be made through the Cancer Drugs Fund or through other means locally."