Drugs / Trifluridine/Tipiracil
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed colorectal cancer 1 milestone | |||||
| 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” 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 3 | NCT04737187 | Nov 2020 → Jul 2022 | colorectal cancer | Taiho Oncology, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2025-01-24 | Taiho Oncology, Inc. | Results Taiho Oncology Presents Real-World Findings for LONSURF® at the ASCO Gastrointestinal Cancers Symposium taihooncology.com ↗
Real-world studies confirm that pairing LONSURF with bevacizumab increases efficacy in patients with metastatic colorectal cancer |
| 2023-08-02 | Taiho Oncology, Inc. | Regulatory FDA Approves LONSURF® (trifluridine/tipiracil) in Combination With Bevacizumab for Adult Patients With Metastatic Colorectal Cancer (mCRC) taihooncology.com ↗ |
| 2023-05-03 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier Announce Publication in the New England Journal of Medicine of Pivotal Phase 3 Data for Trifluridine/Tipiracil (LONSURF®) in Combination With Bevacizumab in Patients With Refractory Metastatic Colorectal Cancer taihooncology.com ↗
The safety profile of the investigational combination was consistent with that of each agent. |
| 2023-04-18 | Taiho Oncology, Inc. | Regulatory U.S. Food and Drug Administration Accepts for Priority Review Taiho Oncology’s Supplemental New Drug Application for the Use of Trifluridine/Tipiracil (LONSURF®) in Combination With Bevacizumab for Refractory Metastatic Colorectal Cancer taihooncology.com ↗
A Priority Review designation by the FDA reduces the review period of the sNDA by four months. |
| 2023-01-17 | Taiho Oncology, Inc. | Results Servier and Taiho Oncology Present Overall Survival Data for Trifluridine/Tipiracil (LONSURF®) In Combination With Bevacizumab in Patients With Refractory Metastatic Colorectal Cancer at 2023 ASCO Gastrointestinal Cancers Symposium taihooncology.com ↗
This improvement in OS represents a 39% reduction in the risk of death in patients with refractory mCRC. |
| 2022-09-12 | Taiho Oncology, Inc. | Results Drug Combination Meets Survival Endpoint in Phase III Pivotal Trial Involving Participants With Refractory Metastatic Colorectal Cancer taihooncology.com ↗
Combining trifluridine/tipiracil with bevacizumab demonstrated the potential to extend survival in these patients who have limited therapeutic options. |
| 2019-10-14 | Taiho Oncology, Inc. | Results Analysis of Patients with Prior Gastrectomy Treated with LONSURF® (trifluridine and tipiracil) Published in JAMA Oncology taihooncology.com ↗
Data from pivotal study demonstrate safety and efficacy regardless of prior gastrectomy in previously treated patients with metastatic gastric cancer (mGC) and gastroesophageal junction (GEJ) adenocarcinoma |
| 2019-02-25 | Taiho Oncology, Inc. | Regulatory FDA Approves Taiho Oncology’s LONSURF® (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma taihooncology.com ↗
Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has approved LONSURF® as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. |
| 2019-01-17 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier Present Data on LONSURF® (trifluridine/tipiracil) at ASCO 2019 Gastrointestinal Cancers Symposium (ASCO GI) taihooncology.com ↗
The results confirmed that LONSURF prolonged survival versus placebo regardless of prior gastrectomy. |
| 2018-10-25 | Taiho Oncology, Inc. | Regulatory FDA Accepts Supplemental New Drug Application for LONSURF® (trifluridine/tipiracil) for the Treatment of Metastatic Gastric/Gastroesophageal Junction (GEJ) Adenocarcinoma; Grants Priority Review taihooncology.com ↗ |
| 2018-10-21 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier Announce Positive Results from LONSURF® (trifluridine/tipiracil) Study Presented at ESMO 2018 Congress and Published in The Lancet Oncology taihooncology.com ↗
The trial met its primary endpoint of prolonged overall survival (OS) and secondary endpoint measures of progression-free survival (PFS), as well as continued to demonstrate LONSURF’s predictable safety and tolerability profile. |
| 2018-06-14 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier to Present Data on LONSURF® (trifluridine and tipiracil) and Key Investigational Compound TAS-120 at ESMO 20th World Congress on Gastrointestinal Cancer 2018 taihooncology.com ↗
A pivotal Phase III trial (TAGS) evaluating LONSURF® plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer refractory to standard therapies met its primary endpoint of prolonged overall survival (OS) (Abstract LBA-002). |
All press releases naming this drug 13 releases
Evidence & citations 2 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 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04737187 ↗ |
| Route | Oral | “orally administered trifluridine/tipiracil” PMID 38953855 ↗ Jul 2024 |