European Commission approves Novartis’ breast cancer drug, Afinitor

Hannah Blake

pharmaphorum

The European Commission has approved Afinitor (everolimus), made by pharma company Novartis, for the treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast cancer. It has been approved for treatment in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

"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. Treatment with Afinitor gives women a new option in the battle against this advanced form of breast cancer, where there remains a significant unmet need."

Hervé Hoppenot, President, Novartis Oncology.

Within the European Union, a woman is diagnosed with breast cancer every 2.5 minutes¹. The European Commission’s approval of Afinitor was based on the Phase III BOLERO-2 (Breast cancer trials of OraL EveROlimus-2) trial of more than 700 patients. The clinical trial showed that those treated with Afinitor plus exemestane more than doubled median progression-free survival to 7.8 months, compared to 3.2 months with exemestane alone.

Afinitor was also recently approved by the FDA for treatment on certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer in the United States.