Bayer’s regorafenib receives CHMP recommendation for liver cancer approval

Bayer has announced that its drug regorafenib has been recommended for EU approval as a second-line liver cancer therapy.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has endorsed approval of regorafenib as a treatment for adult patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar.

In clinical trials such as the phase III RESORCE study, the compound was shown to be the first and only treatment to demonstrate a significant improvement in overall survival in second-line HCC patients who previously had no other options.

A final decision from the European Commission is anticipated within the next two months. If approved, this would be the first treatment advance for this condition in nearly a decade.

Robert LaCaze, executive vice-president and head of the oncology strategic business unit at Bayer, said: "The positive opinion for regorafenib in Europe is great news for patients as it supports our efforts to make this treatment available to as many patients as possible."

Regorafenib is already approved under the brand name Stivarga in more than 90 countries worldwide for the treatment of metastatic colorectal cancer, and in more than 80 countries globally for the treatment of metastatic gastrointestinal stromal tumours.

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