Drugs / Lonsurf

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Lonsurf — 2016-04-25 europa.eu ↗
Approved US (FDA) LONSURF — 2015-09-22 fda.gov ↗

Trials 5

2016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT05848739 Jun 2023 → May 2026 overdue colorectal cancer Sapience Therapeutics Recruiting No outcome recorded
Phase 1 NCT04046887 Sep 2019 → May 2021 pancreatic ductal adenocarcinoma Patrick Joseph Loehrer Sr. Terminated No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT05731947 Apr 2023 → Jun 2025 colorectal cancer Syndax Pharmaceuticals Terminated No outcome recorded
Phase 22 trials
Phase 2 NCT06992258 Oct 2025 → Dec 2027 expected colorectal cancer Criterium, Inc. Recruiting No outcome recorded
Phase 2 NCT06245356 Mar 2025 → Oct 2026 expected colorectal cancer, dihydropyrimidine dehydrogenase deficiency, gastroesophageal adenocarcinoma UNICANCER Recruiting No outcome recorded

Press releases naming this drug 24 releases

DateIssuerRelease
2025-01-24 Taiho Oncology, Inc. Taiho Oncology Presents Real-World Findings for LONSURF® at the ASCO Gastrointestinal Cancers Symposium taihooncology.com ↗
2023-08-02 Taiho Oncology, Inc. 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. 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 ↗
2023-04-18 Taiho Oncology, Inc. 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. 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 ↗
2021-02-04 Taiho Oncology, Inc. National Comprehensive Cancer Network® Provides Updates on Use of LONSURF® (trifluridine and tipiracil) in NCCN Drugs and Biologics Compendium® for Colon Cancer and Rectal Cancer taihooncology.com ↗
2021-01-12 Taiho Oncology, Inc. Taiho Oncology and Servier To Present Data on LONSURF® (trifluridine and tipiracil) at 2021 ASCO Gastrointestinal Cancers Symposium (ASCO GI) taihooncology.com ↗
2020-01-25 Taiho Oncology, Inc. Taiho Oncology Presents Data on LONSURF® (trifluridine and tipiracil) and Futibatinib (TAS-120) at ASCO 2020 Gastrointestinal Cancers Symposium (ASCO GI) taihooncology.com ↗
2019-10-14 Taiho Oncology, Inc. Analysis of Patients with Prior Gastrectomy Treated with LONSURF® (trifluridine and tipiracil) Published in JAMA Oncology taihooncology.com ↗
2019-06-03 Taiho Oncology, Inc. Taiho Oncology and Servier Present LONSURF® (trifluridine and tipiracil) Data at the 2019 ASCO Annual Meeting taihooncology.com ↗
2019-02-25 Taiho Oncology, Inc. FDA Approves Taiho Oncology’s LONSURF® (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma taihooncology.com ↗
2019-01-17 Taiho Oncology, Inc. Taiho Oncology and Servier Present Data on LONSURF® (trifluridine/tipiracil) at ASCO 2019 Gastrointestinal Cancers Symposium (ASCO GI) taihooncology.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as Lonsurf “Either Lonsurf® or Stivarga® administered per the investigator's choice at the respective drug label's dose and schedule.” NCT05731947 ↗
4

NCT04046887 ↗

NCT06245356 ↗

NCT05848739 ↗

NCT06992258 ↗

Route Oral “administered orally” NCT04046887 ↗