Everolimus - About the Center for Drug Evaluation and Research > Everolimus (Accelerated Approval)

FDA granted accelerated approval to everolimus (Afinitor, Novartis), an mTOR inhibitor, for patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require therapy but are not candidates for surgical resection. Afinitor was originally approved in March 2009 for the treatment of adult patients with advanced renal cell carcinoma (RCC) whose disease was resistant to sunitinib or sorafenib.

(October 29, 2010) More Information:
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm231967.htm

full-text:
About the Center for Drug Evaluation and Research > Everolimus (Accelerated Approval)