Drugs / Trifluridine/tipiracil
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 2 | NCT07286695 | Dec 2025 → Dec 2029 expected | colorectal cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2025-11-06 | Treos Bio Zrt | Results TREOS Bio Announces Publication of Phase 1b Clinical Trial Results of PolyPEPI1018 Plus TAS-102 in Refractory MSS mCRC in JCO Oncology Advances treostherapeutics.com ↗
The combination achieved a 53.3% disease control rate (DCR) ; median progression-free survival (mPFS) was 4.0 months and median overall survival (mOS) was 8.7 months , representing promising improvements versus historical TAS-102 monotherapy . |
| 2025-01-24 | Taiho Oncology, Inc. | Results Taiho Oncology Presents Real-World Findings for LONSURF® at the ASCO Gastrointestinal Cancers Symposium taihooncology.com ↗
In two abstracts, Taiho will present findings from real-world retrospective studies demonstrating that pairing LONSURF with bevacizumab, rather than administering LONSURF alone, improves clinical outcomes for the mCRC patient population, including Black patients. |
| 2024-07-03 | TTY Biopharm | Regulatory 接軌國際最新治療趨勢 台灣東洋腸癌新雞尾酒療法獲准藥證 com.tw ↗
食藥署基於歐美核准證明以及臨床試驗報告，亦於3日審核通過Trifluridine/Tipiracil (FTD/TPI)複方口服化療癌藥併用Bevacizumab的「腸癌雞尾酒療法」。 |
| 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 ↗ |
| 2023-06-05 | Treos Bio Zrt | Results Treos Bio Announces Presentation of Final Results from Phase 1b Study of PolyPEPI1018 Immunotherapy for Late-Stage Metastatic Colorectal Cancer at 2023 ASCO Annual Meeting treostherapeutics.com ↗
Final results from the study, conducted by Mayo Clinic in Minnesota, demonstrate that PolyPEPI1018 in combination with TAS-102 improved progression free-survival (PFS) and overall survival (OS) compared to historical data for standard of care TAS-102 alone. |
| 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 ↗
In addition, the median time to worsening of ECOG (Eastern Cooperative Oncology Group) performance-status score was significantly delayed in patients receiving the investigational combination of trifluridine/tipiracil and bevacizumab. |
| 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 ↗ |
| 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. |
| 2020-01-25 | Taiho Oncology, Inc. | Results Taiho Oncology Presents Data on LONSURF® (trifluridine and tipiracil) and Futibatinib (TAS-120) at ASCO 2020 Gastrointestinal Cancers Symposium (ASCO GI) taihooncology.com ↗
hematologic adverse events with LONSURF in subgroups of patients with mild to moderate renal impairment and mild hepatic impairment were manageable and similar to those in the overall patient population. |
| 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 ↗
The safety profile of LONSURF was consistent with studies of the drug in metastatic colorectal cancer (mCRC), and no new safety concerns were reported. |
| 2019-06-03 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier Present LONSURF® (trifluridine and tipiracil) Data at the 2019 ASCO Annual Meeting taihooncology.com ↗
A subgroup analysis from the Phase 3 TAGS trial demonstrates a manageable safety profile and consistent efficacy in patients with previously treated mGEJC. |
| 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 ↗ |
| 2018-06-21 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier to Present Data on LONSURF® (trifluridine and tipiracil) at ESMO 20th World Congress on Gastrointestinal Cancer 2018 taihooncology.com ↗
This trial met its primary endpoint of overall survival (OS) and secondary endpoint measures of progression-free survival (PFS), and safety and tolerability, as well as quality of life. |
| 2018-05-09 | Taiho Oncology, Inc. | Results Taiho Oncology Announces Positive Topline Results from Pivotal Phase 3 Trial of LONSURF® (trifluridine/tipiracil) in Metastatic Gastric Cancer taihooncology.com ↗ |
| 2018-04-13 | Taiho Oncology, Inc. | Results Taiho Oncology Presents Data on LONSURF® (trifluridine and tipiracil) and Key Investigational Compounds at the 109th Annual Meeting of the American Association for Cancer Research taihooncology.com ↗
The safety findings of LONSURF in combination with irinotecan were consistent with the existing safety profiles of each drug, and recommended dosing of LONSURF and irinotecan was identified for further study. |
| 2018-01-20 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier Present LONSURF® (trifluridine and tipiracil) Metastatic Colorectal Cancer (mCRC) Data at ASCO 2018 Gastrointestinal Cancers Symposium taihooncology.com ↗
Taiho Oncology, Inc. and Servier today announced clinical data for LONSURF® (trifluridine and tipiracil) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild type, an anti-EGFR therapy. |
| 2017-10-20 | Taiho Oncology, Inc. | Regulatory Health Canada Grants Priority Review Status to trifluridine and tipiracil for Refractory Metastatic Colorectal Cancer taihooncology.com ↗ |
| 2015-09-22 | Taiho Oncology, Inc. | Regulatory Taiho Oncology, Inc. Announces FDA Approval of LONSURF® (trifluridine and tipiracil) for Refractory Metastatic Colorectal Cancer (mCRC) taihooncology.com ↗
today announced that the U.S. Food and Drug Administration (FDA) approved LONSURF® (trifluridine and tipiracil), formerly known as TAS-102 |
All press releases naming this drug 25 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trifluridine/tipiracil | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07286695 ↗ |
| Known as | FTD/TPI | “Trifluridine/tipiracil hydrochloride (FTD/TPI, Lonsurf®) is an oral antineoplastic agent that has been approved as late-stage chemotherapy for colorectal cancer.” PMID 36623495 ↗ Jan 2023 |
| Known as | Lonsurf | “Trifluridine/tipiracil hydrochloride (FTD/TPI, Lonsurf®) is an oral antineoplastic agent that has been approved as late-stage chemotherapy for colorectal cancer.” PMID 36623495 ↗ Jan 2023 |
| Known as | TAS-102 | “Trifluridine/tipiracil (TAS-102) and fruquintinib are novel antitumor agents for patients with refractory metastatic colorectal cancer (mCRC).” PMID 38202064 ↗ Dec 2023 |
| Route | Oral | “Trifluridine/tipiracil: 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days.” NCT07286695 ↗ |