HLB's 'Lenvatinib' Progresses Smoothly in FDA Review... Passes Mid-Review with No Issues

HLB's liver cancer treatment drug 'Rivoceranib' is progressing smoothly through the U.S. Food and Drug Administration (FDA) review.

Jinyangon, Chairman of HLB Group, is announcing the entry of the liver cancer treatment drug 'Rivoceranib' into the FDA's main review through the company's YouTube channel. [Image source=HLB YouTube]

HLB announced on the 6th that its U.S. subsidiary Elevar Therapeutics recently received notification from the FDA that there were no unusual issues raised during the Mid Cycle Review meeting. The Mid Cycle Review meeting is a meeting hosted by the FDA approximately 3 to 5 months after the New Drug Application (NDA) substantive review begins, where the FDA points out deficiencies in the submitted materials and explains areas for future supplementation. However, since no notable issues were raised during this meeting, the company explained that it confirmed with the FDA that no special supplementary matters have been found so far for the new drug approval.

The FDA also stated that there is no need to hold an Advisory Committee Meeting, a hearing to gather expert opinions during the NDA process. HLB said, "We have already proven the excellent efficacy of the Rivoceranib combination therapy through global Phase 3 clinical trials," and added, "Elevar Therapeutics has many executives with FDA experience, including CEO Jeong Se-ho and Vice President Jang Seong-hoon, who have promptly and smoothly handled the preparation of the new drug application materials and ongoing communication with the FDA."

Han Yong-hae, HLB Group's Chief Technology Officer (CTO), said, “Since the new drug application, several official meetings with the FDA, continuous communication, and on-site inspections of the Rivoceranib manufacturing plant have been conducted over the past six months without major issues, and all procedures are progressing smoothly, which has strengthened the company’s confidence. We will do our best in the remaining review process and also strive to prepare for commercialization so that our new drug can be quickly prescribed to many liver cancer patients who had no other options despite the limitations of existing treatments.”

According to the U.S. Prescription Drug User Fee Act (PDUFA), the deadline for the final approval decision on the Rivoceranib and Camrelizumab combination therapy for liver cancer is May 16 of next year.