HLB is accelerating preparations for the launch of the liver cancer treatment drug 'Lenvatinib,' whose U.S. Food and Drug Administration (FDA) approval decision is approaching next month, including applying for inclusion in U.S. clinical guidelines.
On the 9th, HLB announced that it has completed the application for inclusion in the guidelines of the U.S. National Comprehensive Cancer Network (NCCN). NCCN is an organization formed by a coalition of 32 institutions, including national cancer centers and research institutes in the United States. It publishes guidelines and various medical journals considered the most authoritative clinical guidelines worldwide. The NCCN guidelines provide detailed instructions on disease prevention and diagnosis, which drugs or surgeries to perform primarily depending on the patient's stage or condition, and which treatments to add subsequently. Many physicians prioritize using the treatments recommended by NCCN in cancer therapy.
HLB completed the application for inclusion in the NCCN guidelines earlier this month through its U.S. subsidiary, Eleva Therapeutics, which is handling the sales and approval of Lenvatinib in the United States. The company expressed confidence that "after the new drug approval is completed, the combination therapy of Lenvatinib and Camrelizumab will be registered as a first-line treatment guideline for liver cancer as a preferred recommended therapy.
Currently, the NCCN's preferred first-line treatment regimens for liver cancer include the combination therapies of Avastin with Tecentriq and Imfinzi with Imjudo. However, the Avastin combination therapy has recently seen a sharp decline in market share due to issues such as gastrointestinal bleeding, and the Imfinzi combination therapy has limitations in that its therapeutic effect is not higher compared to other combination therapies. In Phase 3 clinical trials, the Avastin combination therapy failed to demonstrate efficacy in liver cancer patients with non-viral causes such as metabolic-associated steatohepatitis (MASH), and the Imfinzi combination therapy did not prove efficacy in liver cancer patients caused by hepatitis C.
HLB currently plans to advance the sales start date of the Lenvatinib combination therapy, which is scheduled for September 3. Chairman Jin Yang-gon and other key executives visited China’s Hansoh Pharmaceutical to agree on a rapid commercialization strategy and detailed schedule, and conducted inspections of production facilities and distribution networks. Additionally, major tasks such as new drug approval and commercialization procedures, NCCN guideline inclusion, and registration with Pharmacy Benefit Managers (PBMs) are being carried out simultaneously.
Shim Kyung-jae, Executive Director of HLB’s External Cooperation Team, said, “Since HLB’s liver cancer drug has already proven excellent efficacy and safety, it will be registered in the NCCN guidelines without difficulty,” adding, “Eleva is also rapidly advancing commercialization procedures, and internally, we are intensively discussing the expansion potential of the pipeline.”
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