Bayer applies for approval of regorafenib as second-line liver cancer therapy

Bayer has applied for regulatory approval in a number of countries for its oral multikinase inhibitor regorafenib to be utilised as a second-line cancer therapy.

Submissions have been filed with regulators in the US, Japan and Europe for the drug – which is sold under the brand name Stivarga – to be approved as a second-line treatment for patients with unresectable hepatocellular carcinoma.

The therapy is already approved in many countries as a means of treating metastatic colorectal cancer and gastrointestinal stromal tumours. However, there are currently no approved therapies for unresectable hepatocellular carcinoma in the second-line setting.

These regulatory filings are based on data from the phase III RESORCE trial, showing that regorafenib was associated with a 37 percent reduction in the risk of death for patients in this demographic when compared to placebo.

Dr Joerg Moeller, member of the executive committee of Bayer's pharmaceutical division and head of development, said: "These filings bring us a step closer to potentially being able to offer a much-needed second-line option to liver cancer patients in the near future."

Hepatocellular carcinoma is the most common form of liver cancer, accounting for approximately 70 to 85 percent of all liver cancer cases worldwide.

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