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Lilly's Cyramza approved in US for hepatocellular carcinoma sub-population

Published on 13/05/19 at 10:34am

Eli Lilly's vascular endothelial growth factor (VEGF) receptor 2 antagonist Cyramza (ramucirumab) has received approval in the US as a single agent for the treatment of hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥400 ng/mL and have been previously treated with Bayer’s Nexavar (sorafenib), the FDA has confirmed.

In a study of 292 patients in this indication, it was demonstrated that Cyramza, when combined with best supportive care (BSC) and administered every two weeks, improved median overall survival by 8.5 months, compared to 7.3 months  with placebo plus BSC.

Overall survival was the study’s primary endpoint, and the results of the trial succeeded in meeting the FDA’s criteria for the drug to be approved. The recommended dose is 8mg/kg administered intravenously every fortnight.

Matt Fellows

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