Bayer Receives FDA Approval for Second-Line Systemic Treatment of Liver Cancer

Despite rates of new diagnoses and deaths for some types of cancers declining, liver cancer rates have continued to rise. Each year, 780,000 people worldwide are diagnosed with liver cancer. For nearly ten years, there has only been one systemic treatment – from Bayer – available to patients with hepatocellular carcinoma (HCC), the most common form of primary liver cancer. Bayer has now been granted approval by the U.S. Food and Drug Administration (FDA) for a new systemic treatment, this time in second-line HCC patients whose disease has progressed during their initial systemic treatment.

Because liver cancer exhibits few or no symptoms in its early stages, most patients receive a diagnosis after the disease has reached an intermediate or advanced stage when treatment options are scarcer and outcomes more uncertain.

The treatment landscape a decade ago was limited to surgery, liver transplant, ablation, chemotherapy or radiation, or locoregional treatments. These options fell short for patients whose cancer had already progressed too far, or those with chronic liver disease who were not eligible for them. Even in those patients who responded to these treatments, they unfortunately did not work forever. 

A decade ago, Bayer provided the first systemic therapy for patients with advanced HCC, which is now approved in more than 100 countries worldwide and is considered the standard-of-care for patients with HCC.

The approval on the 27th April provides the first treatment to demonstrate significant improvement in overall survival in second-line HCC patients, as shown in an international, multicenter, placebo-controlled Phase III study which served as the basis for the FDA approval. This approval expands Bayer’s leadership in liver cancer and offers a new treatment plan for patients with HCC.

Additional regulatory filings for the product are under review in countries around the world, including the EU, Japan and China. Decisions in the EU and Japan regions are expected later this year.

“Hepatocellular carcinoma is very hard to treat, and with no new treatments in nearly a decade, options have been very limited for physicians and patients. This approval therefore provides a significant step forward in addressing the high unmet need in this patient population.”

Dr. Jordi Bruix, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBEREHD, Spain

“Bayer is proud to have played a significant role in the treatment of hepatocellular carcinoma.

We first embarked on our scientific research in this area 20 years ago. We could not have accomplished this milestone alone: we would like to thank the patients, caregivers and investigators for their participation and engagement in the pivotal study that led to the FDA approval of our systemic therapy in second-line HCC.”

Robert LaCaze, Executive Vice President, Oncology Strategic Business Unit, Pharmaceuticals Division, Bayer

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