An experimental and unlicensed cancer drug has been fast-tracked to NHS patients under a new government scheme.
Pembrolizumab is a treatment for advanced skin cancer and is the first medicine to be approved through the Early Access to Medicines scheme (EAMS), launched in England last April.
The idea is to get pioneering drugs to severely ill patients much sooner.
Drugs signed off through EAMS have been scrutinised by regulators, weighing the risks and benefits.
A green light by the Medicines and Healthcare products Regulatory Agency (MHRA) means doctors anywhere in the UK can prescribe the drug in question before normal licensing procedures – which can take years – are complete.
Melanoma is the sixth most common cancer in the UK and kills more than 2,000 people in Britain each year.
Damage to the skin by the sun’s harmful UV rays increases your risk of developing this cancer.
While advanced melanoma that has spread to other parts of the body may not be curable, targeted treatment can ease symptoms and may extend life.
Clinical trials of pembrolizumab, which is injected into the bloodstream, suggest it has great promise for treating advanced disease…..
Differentiating between malignant melanoma and benign skin moles can be difficult in about 15% of cases, where histopathologic analysis is not straightforward because of ambiguous findings.
A new 23-gene signature test (myPath Melanoma, Myriad Genetics) could be helpful in these instances, researchers working with the company suggest.
The test was developed with a training set and then validated in an independent cohort. The results were published online March 2 in the Journal of Cutaneous Pathology….
Perhaps no other cancer has benefited more from treatment advances in recent years than advanced melanoma. Once a virtual death sentence, these patients now have a reason to be hopeful, thanks to agents approved in the last three years and even better ones in the pipeline, speakers said at the 3rd Annual World Cutaneous Malignancies Congress (San Francisco, October 2014).
“Nearly 20% of patients receiving the anti-CTLA4 antibody ipilimumab (Yervoy, Bristol-Myers Squibb) are alive at five years, and even some patients who had infusions 10 years ago are still living,” says Caroline Robert, M.D., head of the dermatology unit at the Institut Gustave-Roussy in Paris, France, who has led several recent melanoma treatment trials….
… All symptomatic patients may initially receive ipilimumab, alone or in combination with an anti-PD-1/PD-L1 antibody, with BRAF status becoming important when the disease progresses. Re-treatment with combined immunotherapy or with BRAF inhibitors also may be part of the future algorithm….