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In the context of Sorafenib & Hepatocellular Carcinoma (HCC), the FDA approved sorafenib in 2007 for the treatment of unresectable/advanced hepatocellular carcinoma, based on phase III trials (e.g., SHARP) demonstrating an overall survival benefit versus placebo (1, 2, 3). Sorafenib subsequently became the first systemic standard of care for advanced HCC in patients with preserved liver function (typically Child–Pugh A) and those not amenable to or progressing after locoregional therapies (1, 2, 4).
The European Medicines Agency likewise gr…