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…
Drugmaker HLB has resubmitted its application to the U.S. Food and Drug Administration (FDA) for approval of a new liver cancer treatment. The Korean biopharmaceutical company is working with Chinese partner Hengrui Pharma on the combination therapy, which involves rivoceranib and camrelizumab. This resubmission comes after an FDA complete response letter in July, following an initial application filed in January.
The FDA concerns prompted the companies to collaborate with regulators to address the issues. HLB recently completed inspections of their manufacturing facilities, clearing the way for the resubmission of the application. The new filing is based on CARES-310, a global Phase 3 clinical trial with patients suffering from unresectable or metastatic liver cancer. The final analysis of the trial indicates that the combination treatment shows promise.
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- HLB resubmits FDA application for liver cancer treatment koreatimes.co.kr
