HLB subsidiary Elevar Therapeutics obtains FDA approval for FGFR2-targeted anticancer drug 'Repick2'

(Seoul = Yonhap News) Reporter Park Sang-hyun = HLB[028300] announced on the 24th that its U.S. subsidiary Elevar Therapeutics has received product approval from the U.S. Food and Drug Administration (FDA) for the fibroblast growth factor receptor 2 (FGFR2) targeting anticancer drug 'Lipick2' (ingredient name: rirafugratinib).

Repick2 was approved as a second-line treatment for cholangiocarcinoma with FGFR2 fusion or rearrangement, HLB reported.

Lipictu is an oral anticancer drug developed to selectively bind to FGFR2, unlike existing FGFR inhibitors.

An HLB official said, “This is the first case where a domestic pharmaceutical and bio company received approval by directly submitting a New Drug Application (NDA) for an anticancer new drug to the U.S. FDA.”

The company emphasized that Repick2, whose safety and effectiveness have been confirmed in global clinical trials, could be a new treatment option for patients with FGFR2 fusion/rearrangement cholangiocarcinoma.

Cholangiocarcinoma is a rare cancer that occurs in the bile ducts, which are the passageways through which bile produced in the liver moves. It is known that approximately 8,000 people are diagnosed in the United States every year.

Elevar plans to launch ReficTwo in the U.S. in the fourth quarter of this year.

In addition, we are seeking to expand the market and indications by applying to the European Medicines Agency (EMA) for product approval as a treatment for bile duct cancer and conducting clinical trials on patients with other solid tumors with FGFR2 fusion or rearrangement.

Kim Dong-gun, CEO of Eleva, said, “We will do our best to ensure that Repick2 is supplied to medical staff and patients as quickly as possible.”