FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

NICE Finalizes Recommendation for Bayer’s Stivarga

Jan. 16, 2019

NICE issued a final recommendation for Bayer’s Stivarga (regorafenib) as a treatment for advanced unresectable hepatocellular carcinoma, after reaching an agreement that offers the treatment to through UK’s National Health Service at a discount.

The institute recommends the drug only for adults who have used sorafenib and have Child-Pugh grade A liver impairment and are either fully active or at least ambulatory. NICE said that the medicine now meets its criteria to be considered a life-extending drug at the end of a patient’s life.

In most cases, NHS treats advanced hepatocellular carcinoma with sorafenib. For patients who cannot tolerate sorafenib or experience disease progression while taking the drug, the only other option currently is supportive care.

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