Lonsurf for colerectal cancer patients approved by FDA

United States Food and Drug Administration (FDA) has approved Lonsurf (trifluridine and tipiracil) tablets for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

FDA said in announcement issued on Friday that the approved recommended dosage is 35 mg/m2 (based on the trifluridine component and rounded to the nearest 5 mg increment) orally twice daily within one hour of completion of morning and evening meals on Days 1 through 5 and Days 8 through 12 of each 28-day cycle until disease progression or unacceptable toxicity. Do not exceed 80 mg/dose.

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