HLB resubmits FDA application for liver cancer treatment
Korean drugmaker HLB has resubmitted its application for U.S. approval of a combination therapy for advanced liver cancer, renewing its push to bring the target treatment to market after addressing regulatory concerns raised earlier this year. The Korean biopharmaceutical company said Monday that its U.S. subsidiary, Elevar Therapeutics, and Chinese partner Hengrui Pharma submitted the…
Korean pharmaceutical company HLB has resubmitted an application to the U.S. Food and Drug Administration (FDA) for approval of a novel treatment combination for advanced liver cancer. The resubmitted request, filed by HLB's U.S. subsidiary Elevar Therapeutics and Chinese partner Hengrui Pharma, aims to bring the drug rivoceranib in combination with camrelizumab to market as a first-line therapy for liver cancer patients.
This resubmission comes after the FDA issued a complete response letter in July following an initial application Elevar filed in January. The FDA's concerns prompted the companies to collaborate with regulators to address the agency's issues. HLB recently completed inspections of their manufacturing facilities, enabling the companies to resubmit the application.
The resubmission is based on CARES-310, a global Phase 3 clinical trial evaluating the efficacy of the combination treatment in patients with unresectable or metastatic liver cancer. The final analysis of the trial indicates that the combination therapy demonstrates promising results, prompting the companies to seek FDA approval.
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- HLB resubmits FDA application for liver cancer treatment koreatimes.co.kr
