Afinitor’s new UK indication launched
pharmafile | September 20, 2012 | News story | Sales and Marketing | Afinitor, CHMP, Novartis, breast cancer
Novartis’ cancer drug Afinitor has been made available in the UK for patients with the most common form of advanced breast cancer, hormone receptor-positive.
The manufacturer says this is the first major advance for women living with the disease since aromatase inhibitors were introduced more than 15 years ago.
Afinitor (everolimus) blocks the mTOR pathway, which acts as a so-called ‘master switch’, regulating cell growth in various cancers.
In June the CHMP said Afinitor should have a new licence for the treatment of hormone receptor-positive, HER2 negative advanced breast cancer – a view the European Commission endorsed in July.
“Our priority is to now ensure the widest access to this treatment for the thousands of eligible patients who could potentially benefit and live longer without their disease progressing,” said Ibrahim Elhoussieny, UK oncology medical director, Novartis UK & Ireland.
Advanced breast cancer is incurable, with life expectancy for patients estimated at 18-36 months after diagnosis.
The new indication for Afinitor is designed to be used in combination with exemestane in postmenopausal women without symptomatic visceral disease after recurrence or progression, following a non-steroidal aromatase inhibitor.
The Phase III BOLERO-2 study found that Afinitor plus exemestane, a hormonal therapy, more than doubled the time women lived without cancer growth compared to exemestane alone (7.8 versus 3.2 months).
An additional analysis showed Afinitor extended median progression-free survival to 11 months compared to 4.1 months.
Breast cancer in women accounts for approximately 31% of all new cancer cases in the UK, and Novartis believes up to 14,000 patients here could benefit from Afinitor.
The drug is already approved by the European Medicines Agency to treat advanced pancreatic neuroendocrine tumours and advanced renal cell carcinoma after treatment with a VEGF inhibitor, and is currently being considered for this licence by the FDA and several other markets.
Afinitor brought in just under $300 million last year, but this new licence could see it reach blockbuster status, with analysts suggesting global peak annual sales for Afinitor of $1.7 billion in breast cancer alone.
Novartis is also studying the drug for use in patients with HER2-positive breast cancer in two late-stage trials, meaning it could further increase its sales.
Adam Hill
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