Skin cancer drug Pembrolizumab will now be available on the NHS

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Pembrolizumab today approved for use by drugs rationing watchdog Nice
In trials, it was shown to be twice as effective as chemotherapy
In one, 60% of patients who took the drug survived for at least 12 months
Works by making cancer cells ‘visible’ to the immune system

By Ben Spencer, Medical Correspondent For The Daily Mail

Published: 10:07 EST, 7 September 2015 | Updated: 12:26 EST, 7 September 2015

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A revolutionary skin cancer treatment that shrinks tumours has been made available on the NHS.

Pembrolizumab, which doctors describe as ‘jaw-dropping’, was today approved for use by drugs rationing watchdog Nice.

It is one of the first of a new wave of ‘immunotherapy’ treatments, which harnesses the body’s own immune system and teaches it to attack tumours.

In trials it was shown to be twice as effective as chemotherapy, halting and even shrinking tumour growth for 34 per cent of patients with advanced malignant melanomas.

Patients with advanced skin cancer were given fresh hope today after a revolutionary treatment that shrinks tumours was made available on the NHS

Of patients who took chemotherapy alone, only 16 per cent saw their cancer stop progressing.

The prospect for patients with advanced forms of skin cancer are grim.

Until five years ago, when drugs started to rapidly improve, patients with advanced melanomas were typically told they should not expect to live for more than six to nine months.

But in one trial, 60 per cent of patients who took pembrolizumab survived for at least 12 months.

The drug is so new that longer-term survival data does not yet exist, but experts say that the 30 per cent to 40 per cent of patients who respond to the treatment should see their lives significantly extended.

Dr James Larkin, consultant oncologist at the Royal Marsden Hospital in London, who led some of the clinical trials of the drug, said today: ‘I have got patients who have survived for two and a half years, with few side effects.

‘It is fantastic that this drug has been approved for use on the NHS. It is unqualified good news.

‘It is clear that drugs like this are significantly better than drugs we have had before.’

Pembrolizumab, which will be sold under the trade name Keytruda, is the first of a new class of immunotherapies called ‘anti PD-1 inhibitors’ which works by making cancer cells ‘visible’ to the immune system so it can be attacked by the body’s natural defence mechanisms.

It is the first treatment to go through the Government’s Early Access to Medicines Scheme (EAMS), which enabled 500 people with advanced melanomas to access the drug before it was licensed by the European Medicines Agency earlier this summer.

Until five years ago, when drugs started to rapidly improve, patients with advanced melanomas(pictured) were typically told they should not expect to live for more than six to nine months

The new approval means anyone in England with advanced malignant melanoma, for whom another drug, called ipilimumab, hasn’t worked, will be able to access the drug on the NHS.

Up to 1,600 patients a year are expected to benefit.

The drug is taken via an intravenous drip every three weeks, with the dose depending on body weight.

For a woman of average weight - about 11 stone - the drug has a list price of £3,682 per dose, totalling £64,000 a year.

Under the terms of the approval, US drug company Merck, Sharp and Dohme (MSD) agreed to give the NHS a discount on the price, the extent of which is commercially sensitive.

Dr David Chao of the Royal Free in London, said last year that early trial results had taken experts by surprise.

‘What these early trials are showing is that [these new drugs are fulfilling their promise ridiculously fast,’ he said.

‘Some of these results are really astonishing; almost jaw-dropping.’

REVOLUTIONARY DRUG THAT HAS PROLONGED GRANDFATHER'S LIFE

Colin Toovey, 72, has been taking Pembrolizumab for two years - and his tumours keep shrinking

It was little more than a spot, an annoying itchy pimple on Colin Toovey’s right cheek.

‘It was just like something a teenager would have,’ the 72-year-old grandfather of two said.

‘But it got a little bit bigger and a little bit bigger.’

In January 2013 Mr Toovey, who lives with his wife Jill in Headcorn, Kent, was diagnosed with malignant melanoma, a vicious form of lung cancer.

He underwent an 11-hour operation to remove the cancer from his lymph nodes, where it had already spread.

Worse news was to come – he had three large tumours in his lungs.

But Mr Toovey’s luck quickly changed. He was put on a clinical trial for breakthrough drug Pembrolizumab at the Royal Marsden hospital in Chelsea.

Within two doses of the drug – taken via a drip every three weeks - his tumours had shrunk by 76 per cent.

‘I don’t think I would be here without it,’ the retired photographic technician said.

‘And I have had no side effects at all – I feel absolutely fine.

‘I have just had my 32nd dose – I’ve been on it for nearly two years – and the tumours keep shrinking and shrinking.

'The cancer is stable and I am doing absolutely fine.’

Gillian Nuttall, founder of Melanoma UK said: ‘We are delighted that patients with advanced melanoma will now be given another treatment option.

‘Melanoma is a very difficult disease to treat and it is good news that this treatment will now be made available on the NHS.

‘We must express our thanks to everyone who worked tirelessly in achieving this outcome.’

Professor Carole Longson of Nice said: ‘We are pleased to be able to recommend pembrolizumab, the first EAMS drug, in final draft guidance.

‘In 2011, over 13,000 people were diagnosed with malignant melanoma in the UK, and melanoma accounts for more deaths than all other skin cancers combined.’

Life science minister George Freeman said: ‘I am delighted that Merck, Sharp & Dohme has decided to use the Early Access to Medicines Scheme to accelerate access for our NHS patients.’

Mike Nally, managing director of MSD said: ‘We are proud to have helped bring this breakthrough immunotherapy to patients and that the value it can bring has been recognised and enabled patients who could not afford to wait to gain early access.’