Bayer’s stivarga receives EU marketing approval for HCC treatment


The European Commission (EC) has granted marketing authorisation for Bayer’s stivarga (regorafenib) used for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with nexavar (sorafenib).

Regorafenib is an oral multi-kinase inhibitor that helps block multiple protein kinases involved in tumour angiogenesis, oncogenesis, metastasis and tumour immunity.

Bayer’s stivarga is the first and only licensed treatment that has shown a significant improvement in overall survival (OS) rate in patients with second-line HCC, the most common form of liver cancer.

The EC approval is based on data collected from the international, multicentre, placebo-controlled Phase III RESORCE trial.

The study evaluated patients with HCC whose disease had progressed while being treated with nexavar.

"Bayer continues to support the liver cancer community and is committed to ongoing research in the field, as well as continuing to pursue additional regulatory filings for stivarga across the world."

The trial demonstrated regorafenib plus best supportive care (BSC) to provide a significant improvement in OS versus placebo plus BSC.

Bayer Oncology Strategic Business Unit executive vice-president and head Robert LaCaze said: “Liver cancer is often diagnosed late and difficult to treat, but the European Union (EU) approval of stivarga for HCC marks the first treatment advance for patients in nearly a decade.

“Bayer continues to support the liver cancer community and is committed to ongoing research in the field, as well as continuing to pursue additional regulatory filings for stivarga across the world.”

In addition to being approved in the EU, the therapy also received approval in the US and Japan for second-line HCC treatment in April and June this year, respectively.

In addition, stivarga is already approved in several countries worldwide to be used for the treatment of metastatic colorectal cancer or metastatic gastrointestinal stromal tumours.