This article is more than 5 years old. Information may no longer be current.
FDA grants priority review to Stivarga for second-line treatment of HCC
Click Here to Manage Email Alerts
The FDA granted priority review to regorafenib tablets as a second-line systemic treatment for patients with hepatocellular carcinoma, according to the drug’s manufacturer.
The review is based on results from the international, multicenter, placebo-controlled phase 3 RESORCE trial, in which 573 patients with hepatocellular carcinoma (HCC) who previously had disease progression during treatment with sorafenib (Nexavar, Bayer) were randomly assigned (2:1) to receive regorafenib (Stivarga, Bayer) or placebo plus best supportive care.
Patients received 160 mg of regorafenib or placebo once daily for 3 weeks, followed by 1 week of no treatment, for 28-day treatment cycles.
OS served as the primary endpoint. Secondary endpoints included time to progression, PFS, objective tumor response rate and disease control rate.
“Liver cancer is one of the few cancers still on the rise, and though sorafenib has been approved for the treatment of patients with unresectable HCC since 2007, effective second-line systemic treatment options are urgently needed,” Dario Mirski, MD, senior vice president and head of medical affairs for the Americas at Bayer, said in a press release. “The priority review for regorafenib paves the way for us to gain regulatory approval as early as possible for the HCC patients who need it most.”
Regorafenib is currently indicated for the treatment of:
- patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy and, if RAS wild type, an anti-EGFR therapy; and
- patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor who have been previously treated with imatinib mesylate (Gleevec, Novartis) and sunitinib malate (Sutent, Pfizer).