<em>Afinitor</em> Adds Breast Cancer Indication On Strength Of Progression-Free Survival Benefit

Afinitor Adds Breast Cancer Indication On Strength Of Progression-Free Survival Benefit

20 Jul 2012

Lack of crossover in Novartis’ pivotal BOLERO-2 trial could lead to a clean picture of the mTOR inhibitor’s ability to prolong survival, the ultimate gold standard in cancer drug approvals. An interim analysis showed a survival advantage that fell short of reaching statistical significance.

FDA approved a breast cancer claim for Novartis AG’s mTOR inhibitor Afinitor (everolimus) on the strength of a doubling in median progression-free survival in the BOLERO-2 trial, but the agency surely has its eye on a forthcoming final survival analysis, which, thanks to the study’s design, should provide a clear picture of whether the drug makes patients live longer.

On July 20, the agency approved Afinitor for use in combination with Pfizer Inc.’s aromatase inhibitor Aromasin (exemestane) in...