Novartis announced that the FDA has approved Afinitor (everolimus) tablets for the treatment of adults with kidney tumors known as renal angiomyolipomas and tuberous sclerosis complex (TSC), who do not require immediate surgery. This marks the first approval of a medical treatment in this patient population.

The accelerated approval was based on the double-blind, randomized, placebo-controlled, international, multicenter Phase III EXIST-2 (EXamining everolimus In a Study of TSC) trial, which found that 42% of patients on everolimus experienced an angiomyolipoma response vs. 0% of patients in the placebo arm (p<0.0001). The time to angiomyolipoma progression was also significantly longer in patients on everolimus (p<0.0001), and a 26% response rate was seen among those with skin lesions (p=0.0011).

Afinitor, an oral mTor kinase inhibitor, is already approved for advanced renal cell carcinoma after failure of treatment with Sutent (sunitinib; Pfizer) or Nexavar (sorafenib; Bayer and Onyx), progressive neuroendocrine tumors of pancreatic origin (PNET) in unresectable, locally advanced or metastatic disease, and subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis. Afinitor is available in 5mg and 10mg dosage strengths.

For more information call (888) 4-AFINITOR or visit