US regulators will undertake a speedy review of Bayer's application to expand the reach of its cancer drug regorafenib to include the second-line treatment of patients with unresectable hepatocellular carcinoma (uHCC).
Regorafenib, which Bayer describes as an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumour angiogenesis, is already on the market as Stivarga in many countries, including the US, to treat metastatic colorectal cancer and unresectable and/or metastatic gastrointestinal stromal tumours.
The firm's Nexavar (sorafenib) is the only approved systemic first-line treatment for HCC, but effective second-line options are urgently needed to address unmet need in the area.
The US Food and Drug Administration's priority review designation indicates that the regulator believes regorafenib in the could have the potential to offer patients a significant treatment advance in the second-line setting, and means a review will be completed within six months compared to the standard 10.
The submission is based on data from the international, multicenter, placebo-controlled Phase III RESORCE trial, which showed that the drug significantly improved overall survival compared to placebo, resulting in a 37 percent reduction in the risk of death.
Regulators in Europe and Japan are also currently reviewing the drug in the second-line HCC setting.