(Liver Cancer) Stivarga (Regorafenib) — Drug Information
Medical Supporter — إشعار معلوماتي
هذه المقالة ملخص لمعلومات طبية دولية وليست نصيحة طبية، ولا يمكن أن تحل محل تشخيص طبيبك المعالج أو خطة العلاج. المعلومات المعروضة مجمّعة من منشورات عامة وبيانات رسمية لكبرى المؤسسات الطبية اليابانية؛ وتختلف ملاءمة ونتائج أي علاج من مريض لآخر ويجب أن يقيّمها طبيب مؤهل لكل حالة على حدة.
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
Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).
هل تفكر في تلقّي العلاج في اليابان؟ هل تحتاج إلى معلومات ومساعدة؟
نساعدك في تنظيم المعلومات اللازمة للسفر الطبي إلى اليابان، والتواصل مع المؤسسات الطبية اليابانية، وترتيب استشارة رأي ثانٍ.الاستشارة الأولى مجانية؛ سيساعدك المستشار على توضيح الخطوات التالية.
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