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[HEALTH] · United States, South Korea · 3 sources

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FDA approves lirafugratinib for advanced cholangiocarcinoma treatment

lirafugratinib cholangiocarcinoma FDA approval FGFR2 inhibitor HLB

The U.S. Food and Drug Administration (FDA) has approved lirafugratinib (brand name Lyrfigtu) for the treatment of adults with previously treated, unresectable, locally advanced, or metastatic cholangiocarcinoma that harbors an FGFR2 gene fusion or other rearrangement.

Developed by Elevar Therapeutics, a U.S. subsidiary of the Korean firm HLB, the drug is an oral kinase inhibitor administered at a dose of 70 mg once daily. The approval is based on data from the REFOCUS clinical trial, which demonstrated an objective response rate (ORR) of approximately 46% and a median duration of response of 11.8 months. The trial also reported a median progression-free survival of 11.3 months.

This approval marks the third FGFR2 inhibitor to reach the market for this specific type of bile duct cancer. Additionally, HLB is noted as the first Korean biopharmaceutical company to directly secure FDA approval for a global anticancer drug through its own New Drug Application.

Entities

Elevar Therapeutics · FDA · HLB · Lirafugratinib · cholangiocarcinoma

Claims

What the coverage asserts, and how many sources carry each claim.

  • [○ 1 SOURCE] The REFOCUS trial showed an objective response rate (ORR) of approximately 46%. www.pharmacytimes.com
  • [○ 1 SOURCE] The recommended dosage for lirafugratinib is 70 mg taken orally once daily. www.pharmacytimes.com
  • [○ 1 SOURCE] HLB is the first Korean biopharmaceutical company to directly submit a New Drug Application to the FDA and receive approval for a global anticancer drug. www.thebionews.net
  • [● 2 SOURCES] The FDA approved lirafugratinib (Lyrfigtu) for adults with previously treated, advanced cholangiocarcinoma harboring an FGFR2 fusion or other rearrangement. www.thebionews.net · www.pharmacytimes.com
  • [● 2 SOURCES] The median duration of response (mDOR) was 11.8 months. www.thebionews.net · www.pharmacytimes.com
  • [○ 1 SOURCE] Lirafugratinib is the third FDA-approved FGFR2 inhibitor for the treatment of cholangiocarcinoma.
  • [● 2 SOURCES] The median progression-free survival (mPFS) was 11.3 months. www.thebionews.net · www.pharmacytimes.com

Sources

HLB’s bile duct cancer drug ‘rivoceranib’ wins FDA approval – First Korean firm to directly secure anticancer drug approval [www.thebionews.net]
Sequencing FGFR2 Inhibitors in Previously Treated Cholangiocarcinoma [www.cancernetwork.com]
FDA Approves Lirafugratinib for Previously Treated FGFR2-Altered Cholangiocarcinoma [www.pharmacytimes.com]