After getting the thumbs-up in the USA last week, Novartis' Afinitor has now been approved in Europe as a treatment for advanced breast cancer.
The European Commission has approved Afinitor (everolimus) for use in combination with Pfizer's Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer. Specifically, the combo is intended for use in women with recurrence or progression of their cancer after treatment with a non-steroidal aromatase inhibitor.
Herve Hoppenot, Novartis Oncology president, said the approval of Afinitor is "an important milestone marking the first major advance for women in the European Union with hormone receptor-positive advanced breast cancer since the introduction of aromatase inhibitors more than 15 years ago". The company quoted Jose Baselga of the Massachusetts General Hospital who said that "by boosting the effectiveness of endocrine therapy, Afinitor significantly extends the time women with hormone receptor-positive advanced breast cancer live without tumour progression".
He added that the drug, the first mTOR inhibitor to be approved for this disease, "has the potential to redefine the way this common form of advanced breast cancer is treated". Afinitor is already approved in Europe for advanced renal cell carcinoma and for progressive advanced neuroendocrine tumours of pancreatic origin; second-quarter sales rose 72% to $175 million.