EU approves Afinitor (Novartis)for the treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced Breast Cancer - 31-Jul-2012

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

The approval was based on the Phase III BOLERO-2 (Breast cancer trials of OraL EveROlimus-2) trial. The randomized, double-blind, placebo-controlled, multi-center study of 724 patients found that treatment with Afinitor plus exemestane more than doubled median progression-free survival (PFS) to 7.8 months, compared to 3.2 months with exemestane alone (hazard ratio=0.45 [95% Cl: 0.38 to 0.54]; p<0.0001), by local investigator assessment. An additional analysis based on an independent central radiology review showed Afinitor extended median PFS to 11.0 months compared to 4.1 months (hazard ratio=0.38 [95% CI: 0.31 to 0.48]; p<0.0001,