Bayer submitted a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for regorafenib (Stivarga) as a second-line treatment for patients with unresectable hepatocellular carcinoma (HCC), according to a press release.1
Favorable data from the ongoing phase 3 RESORCE (Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma; ClinicalTrials.gov Identifier: NCT01774344) trial led to this submission. This randomized trial includes 573 patients who had disease progression with sorafenib; patients were randomized 2:1 to receive regorafenib or best supportive care.
No study results are yet posted.
The FDA has granted regorafenib Fast Track Designation, which is reserved for therapies that may “address an unmet medical need in the treatment of a serious or life-threatening condition.”
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Regorafenib has been associated with severe to fatal hepatotoxicity, as well as hemorrhage, dermatological toxicity, hypertension, cardiac ischemia and infarction, reversible posterior leukoencephalopathy syndrome, gastrointestinal perforation or fistula, wound healing complications, and embryo-fetal toxicity.
- Bayer submits supplemental new drug application for Stivarga (regorafenib) for advanced liver cancer. Bayer website. http://www.bayer.us/en/article.php?id=123042. Updated November 7, 2016. Accessed November 8, 2016.