The Ministry of Food and Drug Safety announced on the 6th that it has granted approval for the rare drug "Prucaclomide capsules (Prucalopride)" imported by Takeda Pharmaceutical Korea.
Prucaclomide capsules exhibit anticancer effects by inhibiting signaling through vascular endothelial growth factor receptors, which play a crucial role in tumor angiogenesis and growth.
The Ministry noted, "This drug is expected to provide new treatment opportunities for patients with metastatic colorectal cancer who have difficulty being treated with existing therapies."
This treatment can be used for adult patients with metastatic colorectal cancer who have previously been treated with fluoro pyrimidines, oxaliplatin, irinotecan, and anti-VEGF and anti-EGFR therapies, and whose disease has progressed or who are intolerant during treatment with trifluridine/tipiracil and regorafenib.
The Ministry designated Prucaclomide capsules as number 20 in the Global Innovative Products Fast Track Review System (GIFT) and conducted an expedited review. GIFT is a system that rapidly reviews innovative global medical products for life-threatening serious diseases or rare disorders.