Novartis' oral anticancer drug Afinitor has been approved in the EU for the treatment of pancreatic neuroendocrine tumours, adding to its existing indication in renal cell carcinoma.

Afinitor (everolimus) has been cleared for unresectable or metastatic, well- or moderately-differentiated pancreatic NET in adults with progressive disease, on the back of data from the Phase III RADIANT-3 trial which showed it reduced the risk of cancer progression by 65% versus placebo in these patients.Treatment with the drug more than doubled the time without tumour growth from a median of 4.6 months to 11.0 months.

The US Food and Drug Administration (FDA) approved Afinitor in the pancreatic NET indication in May.

Almost two thirds of pancreatic NET patients have advanced disease at diagnosis, with the cancer already spread to other parts of the body, and the five-year survival rate is just 27%.

Afinitor was the first drug in the mTOR inhibitor class to reach the market and has made good progress in the marketplace, bringing in $192 million in the first half of this year.

It is the only approved treatment for patients with advanced renal cell carcinoma following VEGF-targeted therapy with Pfizer's Sutent (sunitinib) or Bayer's Nexavar (sorafenib), and is also approved in the USA and Switzerland (as Votubia) for benign brain tumours (subependymal giant cell astrocytoma; SEGA) associated with tuberous sclerosis.

"We remain committed to the development of everolimus and to further researching the role of mTOR inhibition in multiple tumour types to address significant unmet medical needs for patients," commented Hervé Hoppenot, president of Novartis Oncology.

To that end, Novartis has said it plans to file additional dossiers in oestrogen receptor-positive breast cancer later this year and gastric cancer in 2012. Clinical testing is also being carried out in HER2-positive breast cancer, hepatocellular carcinoma and lymphoma, with filings scheduled from 2013 onwards.