Yes to Yervoy as first line treatment, says NICE
Bristol-Myers Squibb's skin cancer treatment Yervoy should be available as a first line treatment, NICE has said.
The final draft guidance recommends that Yervoy (ipilimumab) is made available on the NHS as a first-line treatment for patients with advanced malignant melanoma which is either unresectable (when the full tumour cannot be removed) or metastatic (the cancer has spread to other parts of the body).
Today's new ruling from the cost effectiveness watchdog represents a reversal of an early decision issued in February, when it concluded that the drug's ability to extend lives had not been proven.
Sir Andrew Dillon, NICE chief executive, said: "We already recommend ipilimumab as a second-line treatment and so we are pleased to be able to propose extending that recommendation to first line treatment too."
NICE says the pharma company submitted further information on how well the drug works, including extra analysis of existing data which showed the degree to which the approved dose of the drug can extend life when compared with the current NHS standard care.
Yervoy's 'list price' is £3,750 per 10-ml vial or £15,000 per 40-ml vial, however BMS has agreed a discount via a patient access scheme.
Next wave of treatments
Just as Yervoy is being accepted for first line treatment in the UK, a new class of drugs are promising an even greater breakthrough in fighting melanoma.
Drugs belonging to the PD-1 (programmed cell death 1) inhibitor class - which stimulate the body's own immune system to fight cancer - are now causing excitement in trials in a number of different tumour types, including melanoma.
Phase Ib trials of Merck's pembrolizumab presented at the recent ASCO conference showed exceptional results in patients. The drug is being studied in a range of different patients sub-groups with advanced melanoma. This includes patients who have already been treated with Yervoy, but whose tumour either did not respond or progressed.
A very high proportion of patients on the trial, 80%, responded to the drug, and after 18 months treatment 62% of patients were still alive and undergoing treatment. A total of 72% of patients experienced tumour shrinkage, with 39% seeing their tumours more than halved in size.
The drug has already been submitted to the FDA, and the US regulator is due to issue its judgement on 28 October. Merck also plans to file the drug in Europe before the end of 2014.
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