Patients in the UK suffering from advanced breast cancer now have a new option for treatment following the launch of Novartis' Afinitor throughout the UK, which the company claims is "the first new therapeutic approach in 15 years offering substantial impact on the disease".
The launch comes hot on the heels of European Union approval for the drug, which granted permission for its use to treat patients with oestrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, in combination with Pfizer's Aromasin (exemestane).
But Afinitor (everolimus) can only be given to postmenopausal women without symptomatic visceral disease after their illness has recurred or progressed despite treatment with a non-steroidal aromatase inhibitor, leaving an eligible treatment population in the UK of up 14,000.
Regulatory clearance has enabled Afinitor to be classed as the first mTOR inhibitor to be approved for this disease, and Novartis has previously said it believes the therapy could redefine the way this common form of advanced breast cancer is treated.
Currently, there is no cure for advanced breast cancer and patients can expect to live just 18-36 months after being diagnosed.
The gold standard of care is endocrine therapy, such as aromatase inhibitors, but unfortunately most patients will eventually develop resistance to treatment, allowing the disease to progress, highlighting the need for new approaches to address this problem.
And this is why Afinitor has the potential to get a significant slice of the market; data from the Phase III, 724-patient BOLERO-2 trial showed that treatment with Novartis' drug plus exemestane more than doubled median progression-free survival to 7.8 months, compared with 3.2 months with exemestane alone.
"For the first time clinical research has identified a therapeutic agent, everolimus, which in combination with exemestane can seemingly circumvent this treatment resistance and substantially reduce the risk of patients cancers worsening," said Professor Stephen Johnston, Professor of Breast Cancer Medicine, at The Royal Marsden NHS Foundation Trust.
Regaring its cost, a spokesman for the company told PharmaTimes UK News that Afinitor is priced at £2,970 +VAT for a 30 day pack of 10mg tablets.
And in terms of a comparison to other therapies on the market, "Afinitor is priced comparably to other innovative targeted anticancer agents licensed in the UK," the spokesperson said.
Afinitor is already approved in Europe for advanced renal cell carcinoma and for progressive advanced neuroendocrine tumours of pancreatic origin, and the drug pulled in second-quarter sales of $175 million this year, which will be propelled further by its availability in advanced breast cancer.
In addition, the drug is also being studied in HER2-positive breast cancer in two ongoing Phase III trials, further adding to its potential.