Novartis' Afinitor Gets EU Nod

Novartis AG’s (NVS - Snapshot Report) cancer drug, Afinitor, recently received approval from the European Commission for the treatment of HR+ HER2- advanced breast cancer in combination with exemestane, in postmenopausal women whose cancer has progressed on an aromatase inhibitor.

The approval did not come as a surprise, as earlier Afinitor had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Phase III data on Afinitor has shown that median progression-free survival (PFS) was more than doubled in patients treated with Afinitor plus exemestane compared to patients on exemestane alone. Treatment with Afinitor improved the median PFS to 7.8 months from 3.2 months with exemestane alone.

EU approval came shortly after Novartis gained approval from the US Food and Drug Administration (FDA) for Afinitor in advanced breast cancer with exemestane, after the failure of treatment with Femara (letrozole) or AstraZeneca’s (AZN - Analyst Report) Arimidex (anastrozole).

Novartis is currently studying Afinitor in two phase III trials for the treatment of HER2-positive breast cancer.

Our Take

We view Afinitor’s approval for the advanced breast cancer as a major positive for Novartis. The label expansion should boost Afinitor revenues significantly. Afinitor, which is already approved for advanced renal cell carcinoma following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy, and locally advanced, metastatic or unresectable progressive neuroendocrine tumors of pancreatic origin posted sales of $443 million in 2011.

Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #3 Rank (Hold rating) in the short run.