Targeted Therapy for Bile Duct Cancer 'Pemazaire' Approved in Korea

Published 25 Apr.2023 09:24(KST)

FEMAZAIRE (active ingredient: pemigatinib), a bile duct cancer treatment introduced by Handok, has successfully obtained domestic approval.

Insight's targeted therapy for cholangiocarcinoma, 'Pemazaire'

On the 25th, the Ministry of Food and Drug Safety announced that it had approved three dosages (4.5 mg, 9 mg, 13.5 mg) of FEMAZAIRE tablets, a targeted therapy for locally advanced or metastatic bile duct cancer.

FEMAZAIRE is an oral FGFR inhibitor developed by Insight in the United States that suppresses the proliferation of cancer cells caused by fibroblast growth factor receptor 2 (FGFR2) fusions or rearrangements involved in cell growth and differentiation. FGFR is a cell membrane receptor that regulates cell growth, survival, and differentiation, and mutations in it can lead to various cancers. FGFR fusions or rearrangements are known to be found in 10-16% of patients with intrahepatic cholangiocarcinoma.

FEMAZAIRE received approval from the U.S. Food and Drug Administration (FDA) as a bile duct cancer treatment in April 2020, and in August last year, its indication was expanded to include treatment for myeloid lymphoid neoplasms. In Korea, it was designated as an orphan drug by the Ministry of Food and Drug Safety in November 2021, and last April, Handok signed an exclusive domestic license agreement with Insight for FEMAZAIRE and another orphan cancer drug, MONJUVI (active ingredient: tafasitamab).

The Ministry of Food and Drug Safety stated, "(FEMAZAIRE) is expected to provide a new treatment opportunity for adult patients with locally advanced or metastatic bile duct cancer with FGFR2 fusions or rearrangements who have received one or more prior systemic therapies."