Drugs / Trifluridine/Tipiracil
Trifluridine/Tipiracil
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed colorectal cancer 2 milestones | |||||
| Filed | EU (EMA) | LONSURF | colorectal cancer | 2023-05-03 | “a type II variation for approval to the European Medicines Agency (EMA)” taihooncology.com ↗ |
| Filed | US (FDA) | LONSURF | colorectal cancer | 2023-04-18 | “the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental new drug application (sNDA) for trifluridine/tipiracil (LONSURF®)” taihooncology.com ↗ “a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA)” taihooncology.com ↗ |
| Filed gastroesophageal adenocarcinoma 1 milestone | |||||
| Filed | US (FDA) | LONSURF | gastroesophageal adenocarcinoma | 2018-10-25 | “the United States Food and Drug Administration (FDA) has accepted and granted priority review for the supplemental New Drug Application (sNDA) for LONSURF®” taihooncology.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT04059562 | Oct 2021 → Jan 2024 | cholangiocarcinoma | Heinrich-Heine University, Duesseldorf | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
All press releases naming this drug 17 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trifluridine/Tipiracil | “Trifluridine/Tipiracil (Lonsurf®) and Irinotecan” NCT04059562 ↗ |
| Known as | FTD/TPI | “Trifluridine/tipiracil (FTD/TPI) and irinotecan have proven efficacy in different gastrointestinal malignancies” PMID 37217885 ↗ May 2023 |
| Known as | Lonsurf | “Trifluridine/Tipiracil (Lonsurf®) and Irinotecan” NCT04059562 ↗ |