FDA approves Afinitor for pancreatic cancer

Novartis has won US Food and Drug Administration (FDA) approval of its marketed cancer drug Afinitor (everolimus) for the treatment of progressive neuroendocrine tumours of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease. With the approval, the product becomes the first new treatment for the indication in about 30 years.

The FDA's decision on Afinitor follows a positive recommendation earlier this month from the FDA's Oncologic Drugs Advisory Committee, which voted unanimously in favour of recommending that the federal agency grant marketing approval for the new indication of PNET tumours, a deadly condition for which few treatment options currently exist.

About 60 per cent of PNET patients are diagnosed with advanced disease, meaning that the cancer has spread to other parts of the body, and the five-year survival rate for these patients is 27 per cent, according to Novartis.

The approval was based on phase III data that showed that everolimus tablets more than doubled median progression-free survival from 4.6 to 11 months when compared with placebo in patients with advanced pancreatic NET. The trial programme, known as RADIANT (RAD001 In Advanced Neuroendocrine Tumours), was the largest ever conducted in patients with advanced PNET.

Everolimus, which targets the mTOR protein, was granted a priority review designation for the treatment of advanced NET of gastrointestinal, lung or pancreatic origin earlier this year. The drug received US marketing approval in 2009 to treat patients with advanced renal cancer whose disease has progressed after treatments with other cancer therapies. In 2010, the FDA granted approval for subependymal giant cell astrocytomas, a tuberous sclerosis complex indication.

In the US, everolimus is also available in different dosage strengths under the trade name Zortress for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant.

Novartis has submitted marketing applications for everolimus for the treatment of patients with advanced NET of gastrointestinal, lung or pancreatic origin to the European Medicines Agency (EMA) and the Swiss Agency for Therapeutic Products (Swissmedic). 

Afinitor is already approved in the EU for the treatment of patients with advanced renal cell carcinoma whose disease has progressed on or after treatment with vascular endothelial growth factor-targeted therapy and is available in the EU in different dosage strengths for the non-oncology patient population under the trade name Certican for the prevention of organ rejection in heart and kidney transplant recipients.