HLB has resubmitted its application to the U.S. Food and Drug Administration (FDA) for a first-line treatment for liver cancer. The company recently completed the manufacturing facility inspection process and is making its fourth attempt for approval.
On October 12, HLB announced that its U.S. subsidiary Elevate Therapeutics and Chinese partner Jiangsu Hengrui Medicine submitted the application for the combination therapy of riboceranib and camrelizumab to the FDA on October 9 (local time). Elevate filed a New Drug Application (NDA), while Jiangsu Hengrui submitted a Biologics License Application (BLA).
This resubmission follows a Complete Response Letter (CRL) issued by the FDA in July regarding Elevate's previous application, which was initially submitted in January. The company stated, "We have addressed the issues raised by the FDA in consultation and have completed the manufacturing facility inspection."
The application is based on results from a global Phase 3 clinical trial. According to HLB, the final analysis showed a median overall survival of 23.8 months for the combination therapy group, compared to 15.2 months for the sorafenib monotherapy group. The risk of death in the combination therapy group was 36% lower than in the control group. HLB noted that this result represents one of the longest survival durations reported in clinical trials for first-line liver cancer treatments.
The final analysis results were published in December of last year in the international journal 'Lancet Oncology.' The combination therapy was presented as a first-line treatment option for liver cancer in the Barcelona Clinic Liver Cancer treatment strategy and the European Society for Medical Oncology guidelines last year.
Kim Dong-keun, CEO of Elevate, stated, "Unresectable liver cancer remains an area with high unmet medical needs. With the manufacturing facility inspection completed, we will work with the FDA to ensure a successful review based on the treatment effects confirmed in clinical trials."
On October 12, HLB announced that its U.S. subsidiary Elevate Therapeutics and Chinese partner Jiangsu Hengrui Medicine submitted the application for the combination therapy of riboceranib and camrelizumab to the FDA on October 9 (local time). Elevate filed a New Drug Application (NDA), while Jiangsu Hengrui submitted a Biologics License Application (BLA).
This resubmission follows a Complete Response Letter (CRL) issued by the FDA in July regarding Elevate's previous application, which was initially submitted in January. The company stated, "We have addressed the issues raised by the FDA in consultation and have completed the manufacturing facility inspection."
The application is based on results from a global Phase 3 clinical trial. According to HLB, the final analysis showed a median overall survival of 23.8 months for the combination therapy group, compared to 15.2 months for the sorafenib monotherapy group. The risk of death in the combination therapy group was 36% lower than in the control group. HLB noted that this result represents one of the longest survival durations reported in clinical trials for first-line liver cancer treatments.
The final analysis results were published in December of last year in the international journal 'Lancet Oncology.' The combination therapy was presented as a first-line treatment option for liver cancer in the Barcelona Clinic Liver Cancer treatment strategy and the European Society for Medical Oncology guidelines last year.
Kim Dong-keun, CEO of Elevate, stated, "Unresectable liver cancer remains an area with high unmet medical needs. With the manufacturing facility inspection completed, we will work with the FDA to ensure a successful review based on the treatment effects confirmed in clinical trials."
* This article has been translated by AI.
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