FDA approved Bayer’s multikinase inhibitor Stivarga® (regorafenib) as second-line therapy for hepatocellular carcinoma (HCC) in patients who have previously been treated with Nexavar® (sorafenib). The firm said the drug is the first new treatment approved in the U.S. for HCC in a decade.
FDA approval followed priority review. Bayer’s regulatory submission of regorafenib for the HCC indication was based on data from the Phase III RESOURCE study in 573 patients, which demonstrated that in comparison with placebo, regorafenib therapy improved overall survival from 7.8 months to 10.6 months, which equates to a 37% reduction in risk of death. The drug is separately undergoing regulatory review for the HCC indication in the EU, Japan, and China.
Commenting on the latest FDA approval, Thomas F. Nealon III, national board chair and chief executive officer of the American Liver Foundation, commented, “Given that the incidence of liver cancer continues to rise, we applaud the efforts of Bayer and the RESORCE study investigators for ushering in this much-needed treatment option for patients with liver cancer.”
In the U.S., Stivarga is already indicated for treating locally advanced, unresectable, or metastatic gastrointestinal stromal tumor (GIST) in patients who have received prior treatment with imatinib and sunitinib. The drug is also cleared in the U.S. for treating colorectal cancer (CRC) in patients who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (anti-VEGF) therapy, and, if RAS wild-type, an anti-epidermal growth factor (anti-EGFR) therapy.
Bayer owns regorafenib, a close relative to sorafenib, which Bayer and Onyx (now an Amgen subsidiary) developed and market jointly. Bayer pays Onyx royalties on oncology-related sales of regorafenib as part of the firms’ 2011 agreement to settle litigation, brought against Bayer by Onyx 2 years earlier, which claimed that regorafenib should be jointly owned as it was discovered through the cancer drug partnership the firms embarked on back in 1994. As part of the settlement agreement, the firms also restructured their sorafenib agreement, with Bayer making a one-off payment to Onyx to end the latter’s rights to receive royalties on sales of Nexavar in Japan.