HLB’s novel drug candidate for bile duct cancer, lirafugratinib, is set to be marketed under the brand name LYRFIGTU in the U.S. The Food and Drug Administration (FDA) is expected to make its final approval decision on September 25.
HLB announced that the FDA has conditionally accepted LYRFIGTU as the brand name for lirafugratinib, an FGFR2-targeted cancer drug being developed by its U.S. subsidiary, Elevar Therapeutics.
The FDA reviews product names prior to granting new drug approvals. A conditionally accepted name becomes official upon final approval. However, this acceptance does not guarantee product approval for lirafugratinib.
Lirafugratinib is being developed as a second-line treatment for patients with advanced or metastatic bile duct cancer who have FGFR2 fusions or rearrangements. The drug is currently under priority review by the FDA, with a target decision date of September 25.
Lirafugratinib is an irreversible inhibitor that selectively targets FGFR2. In the global Phase 1/2 trial ReFocus, it demonstrated an impressive objective response rate (ORR) of 46.5% and a median duration of response (mDOR) of 11.8 months in patients with bile duct cancer harboring FGFR2 fusions or rearrangements.
In anticipation of the final approval decision, HLB and Elevate are gearing up for a U.S. launch.
Kim Dong-geun, Chief Executive Officer (CEO) of Elevar, stated that the FDA’s conditional acceptance of the brand name is a significant step forward as it approaches final approval. It’s now focusing on addressing any remaining questions in the review process and preparing for a swift launch post-approval.
FGFR2, or Fibroblast Growth Factor Receptor 2, plays a crucial role in cell growth and division. Abnormalities such as fusions or rearrangements in the FGFR2 gene can lead to persistent abnormal signaling, potentially promoting cancer cell growth. It’s considered one of the key therapeutic targets in bile duct cancer.
Lirafugratinib has received both orphan drug designation (ODD) in 2022 and breakthrough therapy designation (BTD) in 2023 from the FDA. Elevate submitted a new drug application (NDA) for lirafugratinib to the FDA in January of this year. The agency has granted it priority review status, and the approval process is currently underway. The review deadline, as per the Prescription Drug User Fee Act (PDUFA), is set for September 25.
