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…
Korean biopharmaceutical company HLB is set to receive FDA review for a new drug combination aimed at treating advanced liver cancer. Elevar Therapeutics, Elevar's California-based drug development arm, has resubmitted an application to the FDA to evaluate the therapy, with a decision expected by April 9. The drug being reviewed is a combination of rivoceranib, an oral VEGF-targeting tyrosine kinase inhibitor, and camrelizumab, an anti-PD-1 antibody.
The FDA classified this resubmission as a Class 2, setting the target decision date for April 9 under the Prescription Drug User Fee Act. The review will encompass two separate applications, one from Elevar and another from China's Hengrui Pharma, both resubmitted for Hengrui's biologics license application for camrelizumab. The FDA plans to review these applications jointly to determine the approval potential of the combination therapy.
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- HLB Liver Cancer Drug Re-enters FDA Review, With Decision Due April 9 businesskorea.co.kr
- HLB liver cancer drug enters FDA review, decision expected by April koreatimes.co.kr
