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Lonsurf (trifluridine and tipiracil)Medica

Appendiceal cancer

Initial criteria

  • age ≥ 18 years
  • advanced or metastatic disease
  • Patient meets ONE of the following (i or ii):
  • i. proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
  • ii. ineligible for or progressed on checkpoint inhibitor therapy AND meets ONE of the following (a or b):
  • a) deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease; OR
  • b) polymerase epsilon/delta (POLE/POLD1) mutation positive
  • Previously treated with ALL of the following (i, ii, and iii):
  • i. Fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
  • ii. An anti-vascular endothelial growth factor (VEGF) agent
  • iii. If RAS wild-type (KRAS and NRAS mutation negative), patient meets ONE of the following (a or b):
  • a) anti-epidermal growth factor receptor (EGFR) therapy NOT medically appropriate; OR
  • b) received anti-EGFR therapy

Approval duration

1 year