Bayer secures one-two treatment for liver cancer after EU approval

The approval comes after the treatment had already been approved in the US and Japan for second-line treatment, in April and June respectively. The decision was based on the results from its RESORCE trial showed that the drug was able to improve overall survival (OS) in patients.

In the trial, OS was improved over placebo treatment by just under three months – from 7.8 to 10.6 months. This was translated as a 37% reduction in the risk of death over the duration of the trial period.

Stivarga becomes the first new drug to be approved in the most common form of liver cancer in close to a decade. The figures for survival in the area are still low in the area due to the difficulty in treating cancer once it has reached the liver.

"Until now, there was no effective second-line systemic treatment option for liver cancer patients and their treating physicians in Europe. With the EU approval of Stivarga in HCC, the outlook could significantly improve for patients with HCC, as they have now for the first time, a treatment plan with two approved therapies involving the use of Stivarga directly after Nexavar," said Dr. Jordi Bruix, lead investigator for the RESORCE trial.

Stivarga is currently already used in the treatment of colorectal cancer and in gastrointestinal stromal tumours but has seen sales dip in these areas due to competition.

The expanded indication for treatment will then see a boost in sales that will not detract from sales of Nexavar, which continue to improve after having seen a 10% boost in sales at the beginning of this year. The current cost for treatment of Stivarga, in the US, is $14,881 for one course of treatment.