12.03.2015
Pembrolizumab, an advanced skin cancer treatment, has been scrutinised by regulators to weigh the risks and benefits of its use. The drug can now be prescribed by doctors anywhere in the UK before normal licensing procedures – a process that usually takes years – are complete.
Clinical trials for the drug showed great promise for treating advanced melanoma, easing symptoms and extending life. It is thought to be part of a new generation of cancer care, which focuses on stimulating the body's immune system to fight the disease.
The drug blocks a biological pathway that the cancer uses to disguise itself from attack. Until now, Pembrolizumaab has only been available through clinical trials.
Dr Ian Hudson, chief executive of the Medicines and Healthcare Products Regulatory Agency said: "We are delighted to issue the first positive Early Access to Medicines Scheme scientific opinion.
"The scientific opinion describes the risks and benefits of the medicine and the context for its use, supporting the prescriber and patient to make a decision on whether to use the medicine before its licence is approved."
First Drug To Be Approved Through Early Access To Medicines Scheme Since Launch Last Year
An experimental and unlicensed skin cancer drug has been fast-tracked for treatment of NHS patients, the first to be approved through the Early Access to Medicines scheme (EAMS) since it launched last April.Pembrolizumab, an advanced skin cancer treatment, has been scrutinised by regulators to weigh the risks and benefits of its use. The drug can now be prescribed by doctors anywhere in the UK before normal licensing procedures – a process that usually takes years – are complete.
Clinical trials for the drug showed great promise for treating advanced melanoma, easing symptoms and extending life. It is thought to be part of a new generation of cancer care, which focuses on stimulating the body's immune system to fight the disease.
The drug blocks a biological pathway that the cancer uses to disguise itself from attack. Until now, Pembrolizumaab has only been available through clinical trials.
Dr Ian Hudson, chief executive of the Medicines and Healthcare Products Regulatory Agency said: "We are delighted to issue the first positive Early Access to Medicines Scheme scientific opinion.
"The scientific opinion describes the risks and benefits of the medicine and the context for its use, supporting the prescriber and patient to make a decision on whether to use the medicine before its licence is approved."
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