Nexavar approved for treatment of liver cancer

Nexavar approved for treatment of liver cancer in New Zealand

Auckland, March 17, 2009 – The cancer therapy Nexavar® (sorafenib), initially registered in New Zealand last year for treating advanced kidney cancer, has been approved by Medsafe for treating patients with liver cancer (hepatocellular carcinoma).

Developed by Bayer Schering Pharma and Onyx Pharmaceuticals, Nexavar is a new class of treatment that belongs to a group known as multikinase inhibitors or targeted therapies. It works by slowing tumour growth and reducing the blood supply of the tumour, helping to keep cancer cells from spreading and growing.

Associate Professor Edward Gane, a liver cancer specialist, said the registration of Nexavar for treating liver cancer was a step forward.

“An estimated 150 New Zealanders die annually from liver cancer and this number is expected to double over the next 20 years because of the growing health burden from hepatitis C and hepatitis B, which are the most common causes of liver cancer. An estimated 90,000 New Zealanders have hepatitis B and another 50,000 have hepatitis C.

“Of the 770 cases of liver cancer seen in my Auckland clinic over the last eight years, 24% were Maori and 23% were Pacific Islanders. In most patients, the cancer was diagnosed late when no therapeutic options were available. Less than 20% of newly diagnosed cases of liver cancer were suitable for curative surgery and the average survival was less than three months,” he said.

Nexavar is already approved for liver cancer in Europe and the USA as well as Australia following successful global trial results, which Professor Gane was involved in.

An international phase 3 double blind, placebo controlled trial (known as SHARP) evaluated 602 liver cancer patients who had no prior systemic therapy. Nineteen patients took part from New Zealand.

The trial demonstrated that Nexavar tablets significantly improved overall survival by 44 percent in patients with inoperable liver cancer versus patients who received placebo.

New Zealand clinics are now participating in another study looking at the benefit of Nexavar when used earlier to prevent recurrence after surgery for liver cancer.

Nexavar is also being evaluated by Bayer, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of other cancers.

New Zealand specialists will have a chance to hear more about Nexavar from Dr Josep Llovet, a leading liver cancer specialist from the Barcelona Hospital Liver Clinic, who was also one of the co-principal investigators of the SHARP study. Dr Llovet will be in New Zealand to meet with local specialists on April 6th.

Nexavar is currently unfunded in New Zealand, but an application for funding will be made to Pharmac.

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