Novartis to file breast cancer combination drug Afinitor

Novartis AG  plans to file its breast cancer combination drug Afinitor for global regulatory approval in advanced breast cancer treatment by the end of 2011, submitting promising clinical-trial results at a forthcoming medical congress.

Novartis today said that an interim analysis of 700 patients at over 195 sites worldwide, a pivotal Phase III study showed Afinitor (everolimus) tablets in combination with Pfizer Inc's exemestane significantly extended progression-free survival (PFS), 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. The study included post-menopausal women with ER+HER2- metastatic breast cancer whose disease has progressed, despite initial endocrine therapy.

According to the UK Cancer Research Centre, nearly 1.38 million women world-wide were diagnosed with breast cancer in 2008.

The sale of Afinitor for breast cancer raises the prospects of the product becoming a runaway success and can help Norvatis generate a substantial amount in sales to offset loss from drug-patent expiries.

Afinitor as a medicine for treatment of kidney cancer is expected to generate sales of  around $1.3 billion in 2015, according to a Thomson Reuters forecast.