HLB's liver cancer drug push gains momentum after first FDA approval

What happened: The FDA approved Lyrfigtu, from HLB's US subsidiary Elevar Therapeutics, for previously treated advanced bile duct cancer with FGFR2 fusions or rearrangements on Sept. 23. Why it matters: The approval gave Elevar and HLB experience with the FDA process, and VAI classifications at two manufacturing facilities removed a major obstacle. An official said this does not guarantee rivoceranib approval, as the drugs differ in targets, indications and dossiers.

The FDA approved Lyrfigtu, from HLB's US subsidiary Elevar Therapeutics, for previously treated advanced bile duct cancer with FGFR2 fusions or rearrangements on Sept. 23.

The approval gave Elevar and HLB experience with the FDA process, and VAI classifications at two manufacturing facilities removed a major obstacle. An official said this does not guarantee rivoceranib approval, as the drugs differ in targets, indications and dossiers.