FDA approves Lilly Cyramza monotherapy for patients with hepatocellular carcinoma

, the FDA announced approval of Eli Lilly's Cyramza as a single-drug treatment for patients with hepatocellular carcinoma (HCC). These patients have been treated with sorafenib and have levels of AFP above 400 ng/ml.about Cyramza
Lilly, Cyramza is an antagonist for vascular endotrative growth factor 2 (VEGFR2), which binds specifically to VEGFR2, blocking the binding of this subject to VEGF-A, C, and D, thereby inhibiting vascular growth.Cyramza has been approved by the FDA for the treatment of stomach, non-small cell lung and colorectal cancer.
approval was based on a randomized, double-blind, placebo-controlled multi-center Phase 3 clinical trial that included 292 patients with advanced HCC. These patients have AFP levels above 400 ng/ml and are unable to withstand the treatment of sorafenib or continue to progress after treatment with sorafenib.
the main endpoint of the trial was total survival (OS), and the results showed that the middle OS of patients treated with ramucirumab reached 8.5 months and the value of the placebo group was 7.3 months (HR: 0.71; 95% CI: 0.53, 0.95; p=0.020）。 (Drug Information Network)