The EC approved Novartis’ Afinitor® (everolimus) for the treatment of unresectable or metastatic, well-, or moderately-differentiated neuroendocrine tumors (NET) of pancreatic origin in adults with progressive disease. Regulatory clearance of the mTOR inhibitor applies in all 27 EU member states, plus Iceland and Norway. FDA approval for the pancreatic NET indication was granted in May. Meanwhile, submissions for everilomus in advanced NET are in progress worldwide.
Approval in the EU was based on data from the Phase III Radiant-3 study in patients with advanced pancreatic NET. Results from the study showed that in comparison with placebo, treatment with Afinitor more than doubled progression-free survival (PFS) to 11 months, and reduced the risk of cancer progression by 65%. Consistent improvements in PFS associated with Afinitor therapy were observed in all patient subgroups, including those who had not received prior chemotherapy.
Afinitor is approved in the EU for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy. In the U.S. the drug is approved for the treatment of patients with advanced RCC after failure of treatment with sunitinib or sorafenib and for the treatment of subependymal glial cell astrocytoma (SEGA) in patients who are not eligible for curative surgical resection. Swiss approval of everolimus (trade-named Votubia®) for the SEGA indication was granted in May, and regulatory review in Europe is ongoing.
Also in May, Novartis reported positive data from a Phase III study evaluating Afinitor combined with exemstane, in the treatment of advanced breast cancer. At the time the firm said worldwide regulatory submissions for the drug as a treatment for estrogen receptor-positive, locally advanced, or metastatic breast cancer are planned by the end of 2011.