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Targeted treatment for previously treated cancer
South Korean biopharmaceutical company HLB said the U.S. Food and Drug Administration has approved Rifqtu, a bile duct cancer drug developed by its American subsidiary, Elevar Therapeutics.
The oral targeted therapy selectively binds to fibroblast growth factor receptor 2, or FGFR2. It was approved as a second-line treatment for adults with previously treated, inoperable, locally advanced or metastatic bile duct cancer whose tumors carry FGFR2 gene fusions or other rearrangements.
The approval was based on the global Phase 1 and Phase 2 ReFocus trial, which enrolled 116 patients who had not previously received an FGFR inhibitor. After chemotherapy or a combination of chemotherapy and immunotherapy, participants received 70 milligrams of Rifqtu once daily.
The FDA reported an objective response rate of 46% and a median response duration of 11.8 months. Elevar said median progression-free survival was 11.3 months, with 49.2% of patients remaining free of disease progression at 12 months.
The FDA listed eye toxicity, elevated phosphate levels and soft-tissue calcification, and harm to an embryo or fetus among the drug’s major warnings and precautions.
U.S. launch planned for fourth quarter
Elevar plans to introduce Rifqtu in the United States during the fourth quarter. The company also applied to the European Medicines Agency this month for approval as a bile duct cancer treatment and is studying the drug in patients with other solid tumors carrying FGFR2 fusions or rearrangements.
HLB described the decision as the first time a South Korean pharmaceutical or biotechnology company directly submitted an oncology drug application to the FDA and secured approval. HLB Group Chairman Jin Yang-gon said the company can market Rifqtu globally with patent protection through 2040, adding that its goal had been to complete development independently rather than license the technology to another company.
Additional drugs in development
HLB is also preparing to resubmit its liver cancer drug rivoceranib for U.S. approval. Jin said manufacturing and quality-control issues identified by the FDA at a Chinese partner have been addressed, while the company is compiling updated safety information and additional data from overseas clinical trials.
The company also expects to release Phase 3 global trial results this year for a keratitis treatment candidate from HLB Therapeutics, as well as clinical results for a CAR-T therapy being tested in blood cancer patients by Verismo, the U.S. subsidiary of HLB Innovation.
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