CHMP recommends Afinitor (Novartis) for (HR+) HER2/neu-negative advanced Breast Cancer - 23-Jun-2012

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Afinitor (everolimus) tablets, from Novartis, in combination with exemestane, for the treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced Breast Cancer, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.The CHMP opinion was based on pivotal Phase III data from the randomized, double-blind, placebo-controlled, multi-center BOLERO-2 (Breast cancer trials of OraL EveROlimus-2) trial[3]. The study evaluated 724 patients with HR+/HER2- advanced breast cancer and 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.