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Afinitor gets TGA tick

20 November 2009 Print this article Comments Share this article

A new kidney cancer treatment has been approved by the Therapeutic Goods Administration (TGA).

Afinitor (everolimus) is a targeted therapy for renal cell carcinoma, commonly known as advanced kidney cancer, and is the first proven treatment to benefit patients whose disease has continued to progress after treatment with Sutent (sunitinib) or Nexavar (sorafenib).

"The registration of Afinitor is welcome news for advanced kidney cancer patients and their families," said Associate Professor Ian Davis, medical oncologist, Austin Health and the Ludwig Institute for Cancer Research, Melbourne.

"It now means that this particular group of patients have a new viable, oral treatment option available to them, which can shrink, slow or stop kidney cancer growth."

The TGA registration of Afinitor coincides with its approval by the European Commission earlier this month. It comes following the results of an international clinical trial (RECORD-1) of more than 400 patients, which found Afinitor reduced the risk of disease progression or death by 67 per cent in kidney cancer patients who had been previously treated with other cancer therapies.

It also revealed that Afinitor more than doubled the time to tumour growth or death in patients.

The drug's manufacturer Novartis said it would be working with the Australian Government to make Afinitor available for advanced kidney cancer patients through the PBS in a timely manner. Until that time, it will provide the treatment free of charge to eligible patients.    


Tags: kidney cancer


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