Patients with a certain type of aggressive skin cancer will now have access to a combination of targeted drugs on the NHS in England.
The National Institute for Health and Care Excellence (NICE) has recommended giving the drugs, called dabrafenib (Tafinlar) and trametinib (Mekinist), to people after surgery if their stage 3 melanoma cells carry a certain genetic fault.
Clinical trials have shown the combination treatment can reduce the risk of the disease coming back after surgery.
Both drugs are designed to switch off signals telling cancer cells to grow. They target cells carrying faults in a gene called BRAF, which forces the cells to grow uncontrollably.
Around 16,000 new cases of melanoma are diagnosed each year in the UK. And NICE said that just under 500 people will be eligible for the combination treatment.
The NHS approval came after the manufacturer of the drugs reached a discount deal with NICE.
Emlyn Samuel, Cancer Research UK’s head of policy development, said today’s decision is good news for people affected by this type of skin cancer.
“This drug combination has shown significant benefits for some patients in clinical trials, helping to delay or potentially prevent the relapse of advanced melanoma.”
He said these are the first drugs to be approved to treat these advanced melanomas after surgery, “so we’re pleased to see this important treatment option has now been approved.”
Reduces risk of cancer coming back
Until now, no treatments were available after surgery for this group of patients to stop their cancer returning. Once the cancer comes back after treatment it can be much harder to treat.
Results from a large trial showed the drug combination significantly reduced the risk of melanoma coming back or the patient dying.
In the trial, 870 people with this type of skin cancer were given either dabrafenib and trametinib, or a placebo.
The period after surgery where patients experienced no signs or symptoms of their cancer was significantly longer in the group taking the drug combination.
Three years after treatment, the disease had come back in 37 out of 100 people taking the drug combo, compared to 57 out of 100 in the placebo group.
Fever, fatigue and nausea were the most common side effects experienced by those taking dabrafenib and trametinib.
Ruth Plummer, professor of experimental cancer medicine at Newcastle University, said the treatment has the potential to transform the standard of care for people with this type of advanced melanoma.
“Over half of all patients with stage 3 disease will experience a recurrence in the future, leaving people anxious and worried that their disease might return,” she said.
But Plummer added it’s clear that “treating patients with dabrafenib and trametinib after their surgery reduces the chance of recurrence.”
Stage 3 melanomas are those that have spread into skin, lymph vessels or lymph nodes close to the tumour but not to more distant parts of the body.
There are around 2,285 deaths from melanoma skin cancer in the UK every year.
NICE (2018) Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation- positive melanoma – Final appraisal document