It has been confirmed that Lyfigtu (LYRFIGTU, ingredient name: lirafugratinib), a new bile duct cancer drug developed by HLB's U.S. subsidiary Elevar Therapeutics, has received traditional approval, rather than accelerated approval, from the U.S. Food and Drug Administration (FDA).

The HLB Group announced on the 29th that, according to the FDA approval letter and the disclosure of the U.S. Prescribing Information (USPI), Lyfigtu's authorization falls under formal approval via the standard new drug approval process, not 'Accelerated Approval.' The FDA approval letter stated that the review of the New Drug Application (NDA) has been completed and that the use of Lyfigtu is approved.

Notably, unlike existing competing FGFR inhibitors, which were approved through the accelerated approval pathway, Lyfigtu is the first FGFR inhibitor to receive traditional FDA approval, according to the company.

Accelerated approval is a system that grants expedited authorization based on surrogate endpoints predictive of clinical benefit, such as objective response rate (ORR), and then requires additional proof of clinical benefit through confirmatory trials. In contrast, because Lyfigtu received traditional approval, no confirmatory clinical trials were imposed as a condition for maintaining accelerated approval.

However, the FDA specified two post-marketing requirements (PMRs) and one post-marketing commitment (PMC) to be carried out after approval. One PMR is a clinical trial comparing the safety and anti-tumor activity of Lyfigtu at 70mg with those of lower doses, and the other is a clinical pharmacology trial additionally evaluating drug interactions with P-gp and BCRP substrates. The PMC concerns the development of an FDA-approved companion diagnostic (CDx) to accurately select patients with FGFR2 fusion or rearrangement.

According to the HLB Group, these tasks differ in nature from accelerated approval confirmatory trials, which require re-demonstration of clinical benefit to maintain approval. They constitute follow-up procedures to specify appropriate dosing, safety, and drug interaction information needed in actual prescribing after approval, and to establish a patient selection system.

Accordingly, Lyfigtu's entry into the U.S. market and the progress of its commercialization are expected to emerge as key points of interest for HLB. The company plans to accelerate U.S. commercialization while conducting the post-marketing studies required by the FDA and developing the companion diagnostic.

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