Bayer seeks approval for its liver cancer drug

Bayer on Monday announced the submission of applications to extend the marketing authorization for its oral multi-kinase inhibitor regorafenib in the U.S., Japan and Europe, for the second line treatment of patients with unresectable hepatocellular carcinoma (HCC). Regorafenib is already approved under the brand name Stivarga in many countries to treat metastatic colorectal cancer and metastatic gastrointestinal stromal tumors.

“Almost 10 years ago, we brought Nexavar, the first approved systemic therapy in liver cancer, to patients. We have remained committed to improving the lives of liver cancer patients and are proud that our efforts have yielded a second therapy with an overall survival advantage for patients,” said Dr. Joerg Moeller, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Development. “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.”

Dr. Jordi Bruix, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBEREHD, Spain. Dr. Bruix is the Principal Investigator of the RESORCE study as well as the Phase III study SHARP which investigated sorafenib in HCC, said: “Approximately 780,000 people are diagnosed with HCC worldwide each year, a number that continues to increase. Regorafenib is the first treatment to successfully deliver an overall survival benefit in the second-line setting for HCC and has the potential to change the treatment paradigm by becoming the new standard of care for patients who progress on sorafenib.”

The regulatory submissions for regorafenib are based on data from the international, multicenter, placebo-controlled Phase III RESORCE trial.