HLB liver cancer drug enters FDA review, decision expected by April

Korean biopharmaceutical group HLB is getting a second shot at U.S. Food and Drug Administration (FDA) approval for its flagship liver cancer therapy. The FDA has officially accepted a resubmitted application from HLB’s California-based drug development arm, Elevar Therapeutics, to evaluate a combination treatment for advanced liver cancer, setting a target decision date of April 9. Elevar said the FDA had accepted for substantive review its resubmitted new drug application for rivoceranib, an oral VEGF-targeting tyrosine kinase inhibitor, combined with camrelizumab, an anti-PD-1 antibody, as a first-line treatment for hepatocellular carcinoma. The FDA classified the application as a Class 2 resubmission, setting April 9 as its target decision date under the Prescription Drug User Fee Act. The review covers two applications submitted separately by Elevar and China's Hengrui Pharma, which resubmitted the biologics license application for camrelizumab. The FDA plans to review the applications together to determine whether the combination therapy can be approved. The resubmissions are suppo