Bayer Schering Pharma has this morning launched Nexavar, an oral treatment for hepatocellular carcinoma (HCC), the most common primary liver cancer.
Nexavar (sorafenib) is approved for patients with HCC who are unsuitable for loco-regional therapies and represents an important advance in the management of this deadly malignancy. Nexavar is the first licensed systemic therapy in the UK proven to significantly prolong survival for patients with advanced HCC compared with best supportive care alone.
The European Medicines Agency approved Nexavar based on the Phase III Sorafenib HCC Assessment Randomised Protocol (SHARP) trial. SHARP showed that sorafenib improved overall survival by 44% in patients with advanced HCC compared best supportive care alone. Nevertheless, the prognosis remains relatively poor. Median overall survival was 7.9 and 10.7 months in the placebo and sorafenib groups respectively. The median time to progression was 2.8 and 5.5 months respectively.
Sorafenib seems to be well tolerated. The most common adverse reactions associated with sorafenib, compared with placebo, were diarrhoea (11% and 2% respectively) and hand-foot skin reaction (8% and 1% respectively). Less than 1% of patients developed Grade 4 adverse reactions, the most severe class of side effects.
Nevertheless, adverse reactions continue to emerge as sorafenib is used in an expanding patient population. For example, this month’s Oncologist reports the first case of localised palmar–plantar epidermal hyperplasia, a rare but potentially serious dermatological adverse event, associated with sorafenib.
Nexavar helps meet a desperate need for new treatments for liver cancer. Each year, doctors diagnose approximately 2,800 new cases of primary liver cancer in the UK. Every year roughly the same number of patients dies from the disease, underscoring the poor prognosis. And the problem’s getting worse: the number of primary livers cancer in the UK rose by 44% over the last decade. HCC accounts for between 80% and 90% of primary liver cancer. Only around 5% of HCC patients are still alive five years after their diagnosis. By Mark Greener