The FDA gave an expedited approval for Onyx’s multiple myeloma drug Kyprolis Monday, based on a Phase 2b study of 266 patients. The injection was approved as a third line defense for patients who have failed to respond to at least two other therapies and have had their condition progress within 60 days of their last treatment.
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.
