FDA approves Afinitor for HER-2 negative Breast Cancer - 21-Jul-2012

The FDA has approved Afinitor (everolimus)tablets from Novartis for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative Breast Cancer (advanced HR+ breast cancer) in combination with exemestane after failure of treatment with letrozole or anastrozole. The approval was based on a randomized, double-blind, placebo-controlled, multi-center trial called BOLERO-2 (Breast cancer trials of OraL EveROlimus-2), which evaluated 724 postmenopausal women with advanced HR+ breast cancer with recurrence or progression following prior therapy with letrozole or anastrozole.This pivotal Phase III study 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 .