FDA awards priority review to Bayer's filing for Stivarga as second-line liver cancer treatment

Bayer on Wednesday said the FDA granted priority review to an application seeking approval of Stivarga (regorafenib) for the second-line treatment of patients with hepatocellular carcinoma (HCC). Bayer noted that the priority review designation was supported by data from the Phase III RESORCE trial of patients with HCC whose disease progressed despite treatment with the company's drug Nexavar (sorafenib).

In the study, 573 patients with HCC were randomised to treatment with Stivarga or placebo, both in combination with best supportive care. Results, which were unveiled in May last year, showed that the drug significantly improved overall survival.

Dario Mirski, Bayer's head of medical affairs for the Americas, noted that although Nexavar has been approved for the treatment of patients with unresectable HCC since 2007, "effective second-line systemic treatment options are urgently needed." Bayer submitted Stivarga for approval for the second-line treatment of patients with unresectable HCC in the US, Europe and Japan in November last year.

The company previously identified Stivarga as one of five drugs from which it expects to generate more than 10 billion euros ($10.5 billion) in annual peak revenue. The product is currently authorised in the US for the treatment of certain patients with metastatic colorectal cancer and approved for patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumours.