A PIONEERING drug trialled in the North East that significantly extends the lives of women with advanced breast cancer has been given the green light by regulators.
From today , patients with advanced HER2-positive breast cancer could benefit from the new personalised treatment, Perjeta, which is now authorised for use in the UK.
Newcastle’s Freeman Hospital has been one of the key international centres involved in the development of the drug that stalls disease progression for longer than the gold standard of care.
Perjeta has now been granted a licence by the European Medicines Agency, for patients with previously untreated advanced HER2-positive breast cancer in combination with Herceptin and chemotherapy.
Dr Mark Verrill, consultant medical oncologist at Newcastle Hospitals NHS Foundation Trust, said: “Today’s approval of Perjeta marks an important and much anticipated advance for patients with HER2-positive breast cancer. Perjeta is very effective in HER2-positive disease, extending patients’ lives and keeping the cancer at bay for significantly longer than current standard of care.
“It is a very important development as it represents the biggest single step forward in treatment since the introduction of Herceptin, more than a decade ago.
“It is a step towards developing treatment for early-stage cancer and increasing the cure rate of those with the illness.”
Data from the Phase III Cleopatra study revealed that the drug reduces the risk of death by 34%.
Patients were also seen to live on average 6.1 months longer without their cancer getting worse, compared with those receiving Herceptin and chemotherapy alone.
After one year on treatment, 94% of patients in the Perjeta arm were still alive, compared with 89% in the comparator study.
One woman who knows the importance of treating HER2-positive breast cancer as soon as possible is June Simpson, 55, from Chester-le-Street, County Durham.
The former supply teacher was diagnosed with the illness in April 2011 and is now doing well following a right breast mastectomy and six chemotherapy sessions.
The mother-of-four said: “I am very lucky that my cancer was picked up early and, therefore, was treated as soon as possible.
“It is great news that this new drug has been shown to extend women’s lives and can now be used by patients. Everything possible has to be done to give women precious extra time with their family and loved ones. The cancer trials and research that is being done in the North East is fantastic and it’s great that people in the North East are getting access to the new drugs.”
Perjeta works in a different way to any other cancer medicine. It is the first in a new class of targeted treatments, which work to block cancer cell growth and survival signals.
It is estimated that the drug costs approximately £66,000 per patient for an 18-month cycle, however, negotiations between the drug’s manufacturer, Roche, and the National Institute of Health and Clinical Excellence (NICE) are ongoing to establish a cost-effective price.
Liz Woolf, head of Cancer Research UK’s patient information website, CancerHelp UK, said: “Any improvements in treatment is good news for those with advanced breast cancer, so Perjeta receiving its EU licence is an important milestone.”
Roche is now working with NICE and the Scottish Medicines Consortium (SMC) to ensure patients and clinicians can routinely access Perjeta through the NHS.
In the meantime, patients in England should be able to access Perjeta via the Cancer Drugs Fund or through some private health insurance.
Everything possible has to be done to give women precious extra time with their loved ones
