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In the context of Regorafenib & Colorectal Cancer (CRC), the US FDA approved oral regorafenib in 2012 for patients with metastatic colorectal cancer who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti‑VEGF therapy, and, if RAS wild type, an anti‑EGFR therapy. It is positioned as a later‑line option in treatment‑refractory mCRC and is listed among FDA‑approved third‑line‑plus agents (with trifluridine/tipiracil and fruquintinib) in recent mCRC treatment reviews and NCCN‑aligned discussions (2, 3, 4).
Regorafenib is also [authorized in the EU](brain://QMGe2vnxWkWiArAahJp9aA…