(Liver Cancer) Stivarga (Regorafenib) — Drug Information
Medical Supporter — Information Notice
This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
Germany's Bayer announced on April 28 that the U.S. FDA has approved oral Stivarga (regorafenib) for the second-line treatment of hepatocellular carcinoma (HCC). Regorafenib is a small molecule multi-kinase inhibitor that also holds marketing authorization in Taiwan.
The basis for this U.S. approval was the Phase 3 RESORCE trial results. The trial targeted HCC patients who had previously received sorafenib and had unresectable disease. The regorafenib group received 160 mg once daily for 3 weeks on / 1 week off, in 28-day cycles. The primary endpoint was overall survival (OS), with secondary endpoints including progression-free survival (PFS), time to progression (TTP), response rate, disease control rate, and safety tolerability.
Trial results showed that for the primary endpoint overall survival, the hazard ratio was 0.62 (95% confidence interval: 0.50–0.78), p<0.001, demonstrating a statistically significant benefit in the regorafenib group. The median OS was 10.6 months in the regorafenib group versus 7.8 months in the placebo group. All secondary endpoints were also met.
FDA approval page: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm555608.htm
Stivarga drug information: http://www.bayerpharma.com.tw/scripts/pages/zh/productinfo/cancer/stivarga_film-coated_tablets_40mg/index.php
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