Afinitor expands European licence
pharmafile | September 5, 2011 | News story | Sales and Marketing | Afinitor, Novartis, Pancreatic cancer
Novartis’ Afinitor has made further strides in the EU with an approval for use in patients with advanced pancreatic neuroendocrine tumours.
The manufacturer has high hopes of blockbuster status for Afinitor (everolimus), which had sales of $243 million last year, and this decision does nothing to dent them.
Data from the phase III RADIANT-3 trial showed Afinitor reduced the risk of cancer progression by 65% versus placebo in patients. It is the first mTOR inhibitor approved in the EU for this therapy area.
It can now be used in patients with unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (NET) of pancreatic origin in adults with progressive disease.
Around 60% of pancreatic NET patients have advanced disease, which means the cancer has already spread to other parts of the body, with a five-year survival rate of just 27%.
RADIANT-3 showed treatment with Afinitor more than doubled the time without tumour growth and demonstrated a consistent improvement in progression-free survival in all patient subgroups.
“Today’s approval of Afinitor means that thousands of advanced pancreatic NET patients across Europe will have a new targeted approach for the treatment of this aggressive cancer type for which few therapeutic options are available,” said Hervé Hoppenot, president, Novartis Oncology.
The protein mTOR is important in the development and progression of several cancers, and acts as a regulator of tumour cell division, blood vessel growth and cell metabolism.
“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,” Hoppenot added.
This European decision follows a positive opinion from the CHMP in July, the second time in as many months that a licence extension for the brand received European backing.
Afinitor is already approved in the US to treat benign brain tumours (SEGA), a type of renal cancer, and for the prevention of some organ rejections as well as a type of pancreatic cancer.
In Europe the drug’s SEGA licence has also been recommended for approval and if passed the drug will be marketed for this indication as Votubia.
Novartis also has regulatory submissions for Afinitor in advanced NET underway in several other countries.
Adam Hill
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