New kidney cancer drug gets TGA tick

Novartis Australia's targeted treatment for renal cell carcinoma, everolimus, marketed as Afinitor, has been given the go ahead by the Therapeutic Goods Administration for distribution in Australia.

The drug is approved for use in patients with renal cell carcinoma, commonly known as advanced kidney cancer, after failure of treatment with sunitinib (Stutent) or sorafenib (Nexavar).

Afinitor was approved by the Food and Drug Administration in the U.S. in March and by the European Commission in August 2009.

Afinitor is an orally administered mammalian target of rapamycin (mTOR) inhibitor that has been demonstrated to delay progression of advanced kidney cancer.

mTOR is an intracellular kinase that, when blocked, reduces cell proliferation, angiogenesis and glucose uptake of the targeted cells.

In an international clinical trial of more than 400 patients, Afinitor was found to reduce 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 (4.9 months vs. 1.9 months).

Renal cell carcinoma, the most common type of kidney cancer, originates in the lining of the kidney. It accounts for around 90 per cent of kidney cancer cases and its rates of diagnosis are on the increase.

“Afinitor fulfils an important unmet medical need in treating and managing advanced kidney cancer. Renal cell carcinoma is resistant to standard treatments such as radiation therapy and chemotherapy,” Professor Davis said in a statement.

Afinitor is not currently listed on the Pharmaceutical Benefits Scheme (PBS). To ensure patients have timely access to Afinitor, Novartis will provide the treatment free of charge to eligible patients who are enrolled by their doctor in the Afinitor ACCESS scheme, until such a time that it achieves listing on the PBS.