FDA approves Sirtex cancer treatment

By Iain Scott
Friday, 08 March, 2002

Sydney company Sirtex Medical's novel liver cancer treatment has been approved by the US Food and Drug Administration (FDA), opening the door to what the company says is a billion dollar market. The treatment, selective internal radiation therapy (SIRT), involves the delivery of microscopic radioactive spheres to tumour sites through an injection into the liver's blood supply.

The spheres are trapped in the small blood vessels of liver tumours, which are then irradiated and destroyed from the inside out.

SIRT is already being used for the treatment of liver cancer in Australia and parts of Asia.

The treatment offers new hope to liver cancer patients - the disease has traditionally been considered untreatable, the company said. Unlike current, conventional chemotherapy treatments, the highly specific nature of the SIRT process increases the effectiveness in killing the cancer and minimises side-effects.

Sirtex CEO Dr Colin Sutton said FDA approval enabled the company to sell a revolutionary therapy to the world's biggest market.

"This is the beginning of a very exciting period for Sirtex as a company," he said in a statement.

"Australian companies such as Cochlear and ResMed have already shown success in the global arena by actually creating an entirely new health market. This is precisely what Sirtex has done, with the development of its liver cancer treatments such as SIRT."

First shipments of the spheres to the US are expected to begin within months, and Sirtex is working with key US cancer hospitals towards the treatment of first patients.

Meanwhile, the company is also seeking regulatory approval in all target countries including the European Union and Japan.

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