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