Novartis plans breast cancer filing for Afinitor by year-end

As a result of strong Phase III clinical data with its already marketed kidney cancer drug Afinitor (everolimus), Swiss drug major Novartis (NOVN: VX) says it plans to file for worldwide regulatory approval in the added indication of metastatic breast cancer by the end of the year.

An interim analysis of a pivotal Phase III study showed Afinitor tablets in combination with exemestane (Pfizer’s Aromasin) significantly extended progression-free survival (PFS), or time without tumor growth, when compared to placebo plus exemestane in women with advanced breast cancer. The trial was stopped early after interim results showed the primary endpoint of PFS was met, said Novartis. The study included postmenopausal women with ER+HER2- metastatic breast cancer whose disease has progressed, despite initial endocrine therapy.

Significant sales potential for new indication