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

Korean pharmaceutical firm HLB is poised to receive a second chance at the U.S. Food and Drug Administration (FDA) approval for its leading liver cancer treatment. The FDA has officially acknowledged a resubmitted application from Elevar Therapeutics, Elevar Therapeutics' U.S. division, to assess a combination therapy for advanced liver cancer, with an anticipated decision date of April 9.

Elevar revealed that the FDA has accepted for detailed examination its revised new drug application for rivoceranib, an oral VEGF-targeting tyrosine kinase inhibitor, in tandem with camrelizumab, a monoclonal antibody that targets the PD-1 pathway. This combination is intended to serve as the initial line of defense against hepatocellular carcinoma, a type of liver cancer.

The FDA categorized the resubmission as Class 2, which designates April 9 as the expected decision date under the Prescription Drug User Fee Act. This review encompasses two distinct applications submitted separately by Elevar and China's Hengrui Pharma, which similarly resubmitted a biologics license application for camrelizumab. The FDA intends to concurrently evaluate these applications to ascertain if the combined therapy can be sanctioned.