Company news: Onyx, Novartis
The latest FDA approval in the breast cancer wars may now come with the question “marshmallow or whipped cream.” Novartis announced Friday that its drug Afinitor got the OK for use in women with advanced hormone receptor positive 2 breast cancer in post-menopausal women, if the disease progresses after patients have been on letrozole or anastrozole. Afinitor is taken along with exemestane. Bloomberg reported women were taking the drug off-label, and said patients navigated one of the common side effects – sores on the tongue – by enveloping tablets in marshmallows or whipped cream. The company said in a statement that a double-blind study of 724 women was part of the FDA's grounds for approval. The study said treatment stalled progression for 7.8 months compared to 3.2 months with exemestane alone.