The U.S. Food and Drug Administration (FDA) has rejected, for the third time, the combination of rivoceranib (Tulvegio) and camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (HCC). The decision was based on manufacturing concerns at a facility in China operated by Hengrui Pharma rather than on clinical efficacy or safety data. Elevar Therapeutics and Hengrui plan to address the deficiencies and pursue a resubmission promptly.
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FDA Rejects Liver Cancer Combo for Third Time
US FDA declines to approve Elevar's liver cancer drug ...
HLB, Hengrui receive third US FDA rejection on liver ...
FDA again rejects Hengrui and Elevar's liver cancer combo
US FDA declines to approve Elevar's liver cancer drug ...
FDA snubs another China-made PD-1 with rejection of Elevar, Hengrui's liver cancer combo
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