Afinitor everolimus regulatory update

FDA granted accelerated approval to Afinitor everolimus from Novartis to treat renal angiomyolipomas (non-cancerous kidney tumors) not requiring immediate surgery in patients with tuberous sclerosis complex (TSC). The approval was based on the double-blind, international Phase III EXIST-2 trial in 118 patients that showed Afinitor met the primary endpoint of significantly improving best overall angiomyolipoma response rate vs. placebo (42% vs. 0%, p<0.0001) (see BioCentury, Sept. 26, 2011). Novartis also submitted regulatory applications in the EU in January and in Japan in February for the indication. ...