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FDA approves HLB's phase 1b/2 clinical trial for Colorectal Cancer
HLB announced that they received final approval from the FDA for a Phase 1b/2 trial of metastatic colorectal cancer as a combination with Rivoceranib and Lonsurf®.
HLB officials explained "Global Phase 3 aiming for the first treatment of liver cancer is on the board and in the case of Adenoid Cystic Carcinoma, considering the fact that it could directly go to NDA after the second phase based on the rapid approval procedure, starting next year with gastric cancer, one anticancer drug release per year will be available" and added "We plan to complete the phase 1b/2 in a short period of time and expand to global phase 3 when the drug is validated."
Vice President Ahn Ki-hong said, “Considering the efficacy, low side effects, and patient convenience that has been proved through various routes, Rivoceranib must be a 'qualified new drug' and I expect that this will be confirmed at ESMO."