An unlicensed and experimental new drug has been fast-tracked to skin cancer patients under a new government scheme, in an effort to get pioneering drugs to seriously ill patients much quicker.
Pembrolizumab, a treatment for advanced skin cancer, is the first medicine to be approved through the new Early Access to Medicines scheme (EAMS), which was launched in England last April. Drugs that are signed off through EAMS need to be scrutinised by regulators, who weigh up its risks and benefits.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the drug, meaning doctors anywhere in the UK can prescribe a drug before normal licensing procedures are complete, a procedure which can often take a number of years.
Clinical trials of the drug suggest it has great promise for treating melanoma, a cancer which claims the lives of more than 2,000 people in the UK every year.
The drug is injected into the bloodstream and is considered as a “next generation” drug in the fight against cancer, stimulating the body’s immune system to fend off the disease.
Although clinical trials are still underway, pembrolizumab has already received a US licence for treating advanced melanoma. But, until now, patients in the UK would have only been able to get the drug if they were on a clinical trial.
Dr Ian Hudson, chief executive of the MHRA, 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.”
Emma Greenwood from Cancer Research UK also spoke the “great progress” being made and the move by The Cancer Drugs Fund, another government scheme in England, which funds cancer drugs that have been licensed but not approved by NICE.
“Pembrolizumab is another example of the great progress we’ve made in developing immune treatments for cancer, so it’s encouraging to see it being made available to patients earlier,” she said.
“NICE and the Cancer Drugs Fund only look at licensed drugs, so it’s a step in the right direction in terms of patients getting access to new treatments faster. With this approach, relevant data will be collected and patients are closely monitored.
“We look forward to seeing whether it can be replicated with other promising drugs.”