The Ministry of Food and Drug Safety (MFDS) said it approved Takeda Korea’s Fruzaqla (ingredient: fruquintinib), a metastatic colorectal cancer treatment.
Korea’s MFDS approves Takeda’s Fruzaqla for metastatic colorectal cancer under the expedited GIFT program.
Fruzaqla inhibits signal transduction of vascular endothelial growth factor receptors (VEGFR), which play a crucial role in tumor angiogenesis and growth. The MFDS anticipates that the drug will offer a new treatment opportunity for patients with metastatic colorectal cancer (mCRC) who have limited options with existing therapies.
The drug is indicated for adult patients with metastatic colorectal cancer who have previously undergone treatment with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, as well as anti-VEGF or anti-EGFR therapy (for RAS wild-type patients).
It is specifically approved for patients whose disease has progressed despite treatment with trifluridine/tipiracil and/or regorafenib, or who are intolerant to these therapies.
Notably, Fruzaqla was designated as the 20th product under Korea’s Global Innovative Product on Fast Track (GIFT) system, which expedites the review of globally innovative medical products for life-threatening or rare diseases. Through this system, the MFDS conducted a fast-track review to ensure the drug’s rapid introduction into clinical settings.