Novartis’ Afinitor® (everolimus) significantly extended progression-free survival (PFS) in patients with advanced pancreatic neuroendocrine tumors (pancreatic NET, or islet cell tumors), according to data from a Phase III study. The firm says that it plans to start worldwide approval applications in this indication this year.
The Phase III Radiant-3 study evaluated the treatment of 410 pancreatic NET patients using either everolimus plus best supportive care or placebo plus best supportive care. The trial data is due for presentation at a forthcoming scientific meeting.
“Everolimus was developed to inhibit the mTOR protein, which is a critical target in treating various cancers including NET,” comments Herve Hoppenot, president of Novartis oncology. “These study results will serve as the basis of worldwide regulatory filings for everolimus and bring us one step closer to our goal of offering these patients a new therapy.”
Afinitor is already approved in the EU for the treatment of advanced renal cell carcinoma (RCC) in patients whose disease has progressed despite treatment with vascular endothelial growth factor-targeting therapies.
In the U.S. Afinitor is approved for treating patients with advanced RCC after failure of treatment using Pfizer’s Sutent or Bayer’s Nexavar. Everolimus is also available in the EU as Certican® for the prevention of organ rejection in heart and kidney transplant patients. In the U.S. the drug is marketed as Zortress® for preventing rejection of kidney transplants in adult patients at low-to-moderate immunologic risk.