The FDA on Wednesday approved Taiho Oncology’s Lonsurf (trifluridine and tipiracil) with bevacizumab for metastatic colorectal cancer (mCRC) in those who were previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
The approval, which came 11 days ahead of its PDUFA date, comes almost eight years after the agency approved single-agent Lonsurf for the same indication.
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