Treatment for Advanced Liver Cancer

FIRST EVER TREATMENT FOR ADVANCED LIVER CANCER
NOW AVAILABLE ON PBS*

A milestone has been reached for Australians diagnosed with advanced, inoperable liver cancer (hepatocellular carcinoma) with the availability of Nexavar® (sorafenib tosylate) on the Pharmaceutical Benefits Scheme (PBS) from 1 February.1,2

Patients eligible for Nexavar must meet a strict PBS criteria.

Nexavar is the first systemic treatment to be registered for advanced liver cancer and is also the first therapy shown to extend life, significantly improving overall survival by 44 percent†3.

Paul So, a 64-year-old retired businessman from Victoria, is one of a number of advanced liver cancer patients who will now have access to Nexavar on the PBS. Diagnosed with a reoccurrence of liver cancer in September 2006, Paul has been treated with Nexavar since March 2008.

"My cancer was aggressive and I was told that nothing medically could be done. So when Nexavar became available last year via private prescription my doctor and I decided to give it a try. I started taking Nexavar in March 2008 and within two weeks the pain had reduced and I felt so much better." "I'm feeling much better and am doing most of the things that I used to do. I'm even walking the dog again and we've started a vegetable garden. I feel pretty close to normal and anyone looking at me wouldn't know I have cancer. From a point of despair and hopelessness, we start having a bit of hope. We're now optimistic that with radiation therapy, Nexavar and Qi Gong meditation I'll live longer than originally expected. I feel like a normal 64-year-old and am enjoying time with my family."

In clinical trials, the median time to tumour progression doubled with Nexavar in comparison to placebo with 5.5 months versus 2.8 months3,4. In addition, patients who received Nexavar had a median overall survival of 10.7 months in comparison to 7.9 months for patients who received placebo4. Nexavar targets two types of kinases (enzymes) known to be involved in both cell proliferation (growth) and angiogenesis (growth of a network of new blood vessels that supply nutrients and oxygen to cancerous tissue). It therefore works to inhibit two important processes that enable a cancer to grow3,4. Director of the joint Austin Ludwig Oncology Unit in Melbourne, Prof. Jonathan Cebon, believes the funding of Nexavar on the PBS is good news for patients with advanced liver cancer.

"Nexavar represents a new approach in how we treat advanced liver cancer and an opportunity to provide advanced liver cancer patients who generally have a poor prognosis with more time with their loved ones." said Prof. Cebon.

Patients with advanced liver cancer should discuss the most appropriate treatment options with their specialist.

† The SHARP trial (Sorafenib HCC Assessment Randomised Protocol) was an international Phase III, randomized, multicentre, double-bind, placebo-controlled study to compare the efficacy and safety of Nexavar vs placebo in patients with HCC who had received no prior systemic chemotherapy.

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Issued on behalf of Bayer Schering Pharma by Edelman

PBS CRITERIA FOR NEXAVAR*
From 1 December 2008, the following patients will be eligible for Nexavar (as directed by their treating clinician): Nexavar, as the sole PBS subsidised agent, is to be administered as an initial treatment of advanced (BCLC Stage C††) HCC in a patient with a WHO performance status of 2 or less and Child Pugh class A1. HCC patients who fit the criteria should take Nexavar 400mg orally twice daily (2 x 200mg tablets), with treatment continued until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs3. †† Barcelona Clinic Liver Cancer (BCLC) staging classification

About Nexavar (sorafenib tosylate)
Approved indication: NEXAVAR (sorafenib tosylate) USE Treatment of patients with advanced renal cell carcinoma and advanced hepatocellular carcinoma. CONTRAINDICATIONS Known severe hypersensitivity to sorafenib or any of the excipients in the tablet. PRECAUTIONS Pregnancy and Lactation; Effects on ability to drive and use machines; Dermatological Toxicities; Hypertension; Haemorrhage, Warfarin; Wound Healing Complications; Cardiac Ischemia and/or Infarction; Gastrointestinal Perforation; Hepatic Impairment. Drugs metabolised via the UGT1a1 pathway, docetaxel. ADVERSE EFFECTS Lymphopenia; hypophosphataemia; haemorrhage (inc. gastrointestinal & respiratory tract and cerebral haemorrhage); hypertension; diarrhoea; nausea; vomiting; rash; alopecia; hand foot syndrome; pruritus; erythema; fatigue; pain (including mouth, abdominal, bone pain, headache and tumour pain); Increased amylase; increased lipase. Others see full PI. DOSAGE AND ADMINISTRATION The recommended daily dose of NEXAVAR is 400 mg (2 x 200 mg tablets) taken twice a day, either without food or together with a moderate fat meal. Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction of NEXAVAR therapy. When dose reduction is necessary, the NEXAVAR dose should be reduced to two tablets of 200 mg once daily (see PRECAUTIONS).

Please review Product Information before prescribing. Product Information is available on request from Bayer Australia Ltd.
PBS Information: Authority required. Hepatocellular carcinoma.
Refer to PBS schedule for full details
References:
1. Official PBS Notification Letter from the PBS to Bayer Healthcare
2. Public Summary Document, Sorafenib tosylate submission for PBAC consideration, July 2008. Available online http://www.aodgp.gov.au/internet/main/publishing.nsf/Content/476AD21452D973D8CA2574EB0079B45F/$File/Sorafenib%20PSD%20Bayer%20Australia.pdf
3. Llovet J et al, NEJM; 2008; 359: 378-390
4. Nexavar® Product Information