HLB's 'Lenvatinib' Enters FDA Full Review... Final Decision Expected in May Next Year

HLB's liver cancer treatment drug, 'Rivoceranib,' has entered the formal review process by the U.S. Food and Drug Administration (FDA).

On the morning of the 17th, Jin Yang-gon, Chairman of HLB Group, announced through the company's YouTube channel, "HLB's U.S. subsidiary, Elevar Therapeutics, officially received notification from the FDA at 10:30 PM Korean time on the 14th that the New Drug Application (NDA) filing acceptance has commenced." This marks the start of the formal review 15 years after the development of Rivoceranib began in 2008.

HLB's U.S. subsidiary Elevar completed a global Phase 3 trial of the combination therapy of Rivoceranib and Hansoh Pharmaceutical's immuno-oncology drug 'Camrelizumab' and submitted the NDA for Rivoceranib as a first-line treatment for liver cancer to the FDA on May 16. With the FDA initiating the NDA review under the standard review process, the decision on drug approval is expected by May 16 next year, within 10 months at the latest, according to the Prescription Drug User Fee Act (PDUFA). PDUFA allows the FDA to collect fees from applicants to expand review personnel and proceed with the full review.

Regarding the review proceeding under the standard review rather than the priority review, Chairman Jin emphasized, "the two review types differ only by about four months in the FDA's administrative schedule and are unrelated to the approval decision." He explained, "Priority review is chosen when there is an unmet need, meaning no approved treatment exists for the indication, or existing treatments do not meet patient needs. Otherwise, it involves purchasing a voucher as a kind of expedited fee to apply for priority review."

Therefore, Chairman Jin regarded this as an expected and rather fortunate outcome. He stated, "(Rivoceranib) does not qualify as an unmet need since first-line treatments already exist," adding, "although we attempted priority review due to excellent clinical results in overall survival (OS) and progression-free survival (PFS), we anticipated it would not be easy based on precedent." Regarding voucher purchase, which recently traded at around 140 billion KRW, he said, "shareholders would likely not agree to buying a voucher just to shorten approval by four months," and added, "we thought it better to use that money for marketing." Furthermore, since Hansoh Pharmaceutical had prepared related procedures assuming a standard review, if priority review were granted, there would be insufficient time to respond to chemistry, manufacturing, and controls (CMC) inspections, so this actually bought more time.

Chairman Jin also conveyed that "they were notified that the advisory committee meeting, a typical hearing procedure during the approval process, will be omitted 'under current standards.'" He explained, "while various interpretations are possible regarding the omission of the hearing process, for us, it reduces cumbersome procedures, making the NDA process smoother," and added, "it also has the side benefit of saving about 2 billion KRW in expenses."

HLB logo
Photo by HLB

Jeong Se-ho, CEO of Elevar, said, “With the formal NDA submission, the combination therapy of Rivoceranib and Camrelizumab has reached an important milestone toward becoming a treatment for unresectable liver cancer,” and added, “We earnestly hope that through close cooperation with the FDA during the remaining process, liver cancer patients will soon be able to improve treatment outcomes and quality of life with the Rivoceranib combination therapy.”

With the commencement of the formal review, HLB plans to accelerate preparations for commercialization, including expanding drug sales licenses and establishing joint marketing strategies, while also working closely with Hansoh Pharmaceutical to prepare for the upcoming FDA CMC inspection.

Chairman Jin Yang-gon shared his thoughts, saying, “We have set very ambitious internal goals and are progressing step by step,” and expressed confidence that “the challenges and boldness demonstrated so far in developing a difficult global anticancer drug will enable us to achieve our goals.”

This content was produced with the assistance of AI translation services.