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Merck’s cancer drug sees first ever early access nod

pharmafile | March 11, 2015 | News story | Sales and Marketing Cancer, ICR, Merck, eams, early access, keytruda, melanoma, oncology, pembrolizumab 

Merck’s skin cancer drug Keytruda has become the first drug to be approved through the new Early Access to Medicines Scheme (EAMS).

Keytruda (pembrolizumab) has been fast-tracked to patients via the system which aims to give people with life threatening or seriously debilitating conditions access to medicines that do not yet have marketing authorisation.

The treatment works by making cancer cells ‘visible’ to the immune system so they can be destroyed by the body’s natural defence mechanisms. Clinical trials have shown improvement in the prognosis for patients with advanced melanoma when treated with the drug.

Commenting on the news Professor Paul Workman, who is the chief executive of The Institute of Cancer Research, says: “Today’s announcement is an important step in moves to get innovative and effective cancer drugs to patients more quickly and more cheaply. We need to be much more open to fast tracking the best drugs to patients, without the requirement for very large amounts of data from big Phase III trials.

“But equally, pharmaceutical companies must pass on the savings in drug development costs in the form of lower initial prices, and we must then closely monitor the performance of these new drugs as they are used on the NHS.”

The scheme was introduced by the government in 2014 to help patients benefit from promising, innovative treatments before a European licence has been granted. The Medicines and Healthcare products Regulatory Agency (MHRA) give a scientific opinion on the benefits of the medicine, based on the data available when the EAMS submission is made.

Managing director for Merck’s UK and Ireland division, Mike Nally, says: “We welcome the government’s proactive approach in facilitating early access to the most promising innovative medicines and are delighted that pembrolizumab will be the first to reach those patients who have limited remaining options through EAMS.”

He adds: “This is good news for those people with advanced melanoma in the UK, many of whom could not have waited for the traditional approval timelines and will now be able to access the treatment through EAMS months before the granting of a licence and NICE’s formal assessment.”

Merck suggests that a substantial number of people across the UK with advanced melanoma are expected to benefit from accelerated access to the drug, which under EAMS will be provided to the NHS free of charge.

Melanoma is considered advanced when the cancerous cells spread to other parts of the body causing a new a cancer – known as secondary or metastasis – to grow. According to Macmillan Support about 12,800 people in the UK are diagnosed with melanoma each year. It is one of the most common cancers in people aged 15–34 but like most cancers, it is more common in older people.

UK minister for life sciences, George Freeman, concludes: “Today’s announcement shows that the UK is now leading in the global race to accelerate access to medical innovations, which is key to our economic health.”

Tom Robinson

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