Regorafenib is only the second agent approved by the FDA for the treatment of patients with advanced-stage hepatocellular carcinoma. Herein, we discuss the evidence that led to the approval of this agent. Examination of this process reveals important challenges associated with drug regulation, relating to trial design, treatment toxicity, and real-world clinical benefit.

中文翻译：

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卫生政策：收益有限的中型药物-雷格非尼治疗HCC的故事

Regorafenib仅是FDA批准用于治疗晚期肝细胞癌患者的第二种药物。在此，我们讨论导致该代理人批准的证据。对这一过程的检查揭示了与药物监管相关的重要挑战，涉及试验设计，治疗毒性和实际临床益处。