HLB Resubmits FDA Application for Liver Cancer Combination Therapy

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HLB has resubmitted its application to the U.S. Food and Drug Administration (FDA) for approval of its combination therapy for first-line treatment of liver cancer, incorporating additional data and improvements requested during the previous review. Its U.S. subsidiary Elevar Therapeutics filed a New Drug Application for rivoceranib, while partner Jiangsu Hengrui Pharmaceuticals submitted a Biologics License Application for camrelizumab, with the FDA reviewing the two drugs as a single therapy.

In a global Phase 3 trial, the rivoceranib–camrelizumab combination achieved a median overall survival of 23.8 months in patients with unresectable hepatocellular carcinoma, the longest reported among current first-line treatments. The therapy has already been included in the 2025 BCLC strategy and ESMO guidelines, highlighting its clinical relevance. HLB said it will work closely with the FDA during the review process to improve the likelihood of approval.

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HLB Resubmits FDA Application for First-Line Liver Cancer Combination Therapy - IT타임스