Press Releases

Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML

• NDA is supported by data from the phase 3 ASCERTAIN study of oral C-DEC in adults with intermediate- and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML)
• FDA designated the application for Priority Review
• Potential for oral C-DEC to become first approved orally administered hypomethylating agent for MDS and CMML in the U.S.

PLYMOUTH MEETING, PA [January 27, 2020] — The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) today announced plans to evaluate futibatinib (TAS-120), a potent and selective inhibitor of the fibroblast growth factor receptor (FGFR). The project will include pre-clinical, translational and clinical trials using futibatinib as monotherapy and in biologically relevant combination regimens for malignancies with FGFR 1-4 aberrations. This project will be the first NCCN research program to study an FGFR inhibitor. Specific research areas will be determined by a group of cancer research experts from NCCN Member Institutions who form a Request for Proposals (RFP) Development Team. The research funding is supported by a $2-million grant from Taiho Oncology.

“We’re excited to help facilitate new research into innovative ways for managing cancer,” said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. “We still have a lot to learn about FGFR signaling and how to optimally target this receptor as a component of cancer therapy. We look forward to the potential new discoveries that may come from these investigations.”

PRINCETON, N.J., January 25, 2020 – Taiho Oncology, Inc. announced today the presentation of a pooled analysis for hematologic adverse events of the global Phase III TAGS and RECOURSE trials evaluating LONSURF^® (trifluridine and tipiracil) in patients with metastatic colorectal cancer (mCRC) and metastatic gastric or gastroesophageal junction cancer (mGC/GEJC), respectively. The company also presented updates on two trials in progress with futibatinib, the Phase III FOENIX-CCA3 study of futibatinib as first-line treatment for patients with advanced cholangiocarcinoma (CCA) harboring FGFR 2 gene rearrangements and a Phase II basket study of futibatinib in patients with advanced solid tumors harboring FGFR genomic aberrations.

PRINCETON, N.J., November 1, 2019 – Recognizing a need for greater awareness and education around gastric cancer, Taiho Oncology, Inc., today announced its support of four leading gastric cancer advocacy organizations in observance of National Gastric Cancer Awareness Month. The company is sponsoring patient and caregiver programs, education and research throughout 2019 on behalf of Debbie’s Dream Foundation, the Gastric Cancer Foundation, Hope for Stomach Cancer and No Stomach For Cancer^®.

PRINCETON, N.J., October 14, 2019 – Taiho Oncology, Inc. announced today that detailed results from the analysis of patients with prior gastrectomy enrolled in the Phase 3 TAS-102 Gastric Study (TAGS) evaluating LONSURF^® (trifluridine and tipiracil) in 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, were published in the October 10, 2019 issue of JAMA Oncology.

PRINCETON, N.J., June 7, 2019 – Taiho Oncology, Inc. announces that it has assumed commercialization responsibility from Otsuka Pharmaceuticals Co., Ltd., (Otsuka) for the novel fixed-dose combination of cedazuridine and decitabine (ASTX727) and guadecitabine (SGI-110) in the U.S. and Canada, subject to regulatory approvals. Taiho Pharma Canada, Inc., will commercialize these compounds in Canada.

PRINCETON, N.J., June 3, 2019 – Taiho Oncology, Inc. and Servier announced today clinical data with LONSURF^® (trifluridine and tipiracil, TAS-102) in previously treated patients with metastatic gastric cancer (mGC), metastatic gastroesophageal junction adenocarcinoma (mGEJC) and metastatic colorectal cancer (mCRC) were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

PLYMOUTH MEETING, PA [March 14, 2019] — The National Comprehensive Cancer Network^® (NCCN^®) Oncology Research Program (ORP) has funded three investigators from NCCN Member Institutions through a collaborative scientific research relationship with Taiho Oncology, Inc. to further evaluate the clinical effectiveness and safety of trifluridine and tipiracil (TAS-102) for treatment of various advanced, solid tumors.

PRINCETON, N.J., March 1, 2019 – Taiho Oncology, Inc., in partnership with leading advocacy groups including Colorectal Cancer Alliance, Fight Colorectal Cancer and COLONTOWN^®, today announced its support of a number of prevention and awareness initiatives during National Colorectal Cancer Awareness Month. Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer and the second leading cause of cancer death in the United States, with an estimated 140,250 new cases and 50,630 deaths in 2018.

PRINCETON, N.J., February 25, 2019 – 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.

PRINCETON, N.J., January 17, 2019 – Taiho Oncology, Inc. and Servier announced today that the safety and efficacy in patients with gastrectomy from the global Phase 3 TAGS trial evaluating LONSURF^® in patients with previously treated metastatic gastric cancer (mGC) are consistent with the overall study results published in The Lancet Oncology. These data were highlighted at the ASCO 2019 Gastrointestinal Cancers Symposium (ASCO GI) on Thursday, January 17 during an oral presentation at 2:45 PM PST and during a poster presentation at 11:30 AM-1:00 PM and 5:30 PM-6:30 PM PST. Additional data with LONSURF in metastatic colorectal cancer (mCRC) patients will be presented during a poster session on Saturday, January 19.

PRINCETON, N.J., October 25, 2018 – Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has accepted and granted priority review for the supplemental New Drug Application (sNDA) for LONSURF^® (trifluridine/tipiracil, TAS-102) as a treatment for patients with previously treated, advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of February 24, 2019.

NCCN Awarded $2 Million in Research Funding from Taiho Oncology to Study Trifluridine and Tipiracil in Various Cancers The National Comprehensive Cancer Network’s Oncology Research Program received a grant to investigate effectiveness of trifluridine and tipiracil for treatment of people with colorectal, gastric, and other cancers

PRINCETON, N.J., October 21, 2018 – Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan) and Servier jointly announced today the clinical data from the pivotal Phase III (TAGS) trial evaluating LONSURF^® (trifluridine/tipiracil, TAS-102) versus placebo and best supportive care in patients with heavily pretreated metastatic gastric/gastroesophageal junction (GEJ) cancers who have progressed or are intolerant to previous lines of therapy. 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. TAGS, a phase 3, randomised, double-blind study of trifluridine/tipiracil (TAS-102) versus placebo in patients with refractory metastatic gastric cancer (Abstract #LBA25), data were presented by Hendrik-Tobias Arkenau, MD, PhD, from the Sarah Cannon Research Institute (UK) at the ESMO 2018 Congress in Munich, Germany during an oral session on Sunday, October 21 at 11:10 AM CEST. The study results were simultaneously published in The Lancet Oncology.

PRINCETON, N.J., September 28, 2018 – Taiho Oncology, Inc. today announced real-world adherence data for patients with metastatic colorectal cancer (mCRC) who were treated with LONSURF^® (trifluridine and tipiracil) or Stivarga^® (regorafenib).* In this retrospective study, medication adherence was assessed among adult patients with mCRC receiving LONSURF (469) or regorafenib (311). Treatment with LONSURF was associated with significantly higher medication adherence and longer time to discontinuation compared to treatment with regorafenib. These data, from the IQVIA™ Real-World Data Adjudicated Claims-US database, will be presented by Anuj Patel, MD, Dana-Farber Cancer Institute, at the 2018 ASCO Quality of Care Symposium (ASCO QCS) in Phoenix during Poster Session A on Friday, September 28, from 11:30 AM to 1:00 PM and 5:15 PM to 6:15 PM PT.

PRINCETON, N.J., June 21, 2018 – Taiho Oncology, Inc. and Servier today announced clinical data from the pivotal Phase III trial (TAGS) evaluating LONSURF^® (trifluridine and tipiracil, TAS-102) plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer refractory to standard therapies. 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. The data were presented as oral and poster presentations at the ESMO 20th World Congress on Gastrointestinal Cancer 2018 (ESMO-GI) in Barcelona, Spain, June 20 to 23.

PRINCETON, N.J., June 20, 2018 – Taiho Oncology, Inc. today announced a Phase I study to examine the efficacy of TAS-120, an investigational irreversible pan-fibroblast growth factor receptor (FGFR) inhibitor as a potential treatment for patients with advanced solid tumors, including cholangiocarcinoma (CCA), who were previously treated with chemotherapy or other therapies including other FGFR inhibitors. This is a presentation of updated clinical data for TAS-120 in cholangiocarcinoma, a rare cancer with limited treatment options. These data were presented as oral and poster presentations on Wednesday, June 20 at 2:50 PM CEST at the ESMO 20^th World Congress on Gastrointestinal Cancer 2018 (ESMO-GI) in Barcelona, Spain, June 20 to 23.

PRINCETON, N.J., June 14, 2018 – Taiho Oncology, Inc. and Servier today announced that clinical data for LONSURF^® (trifluridine and tipiracil, TAS-102) are being presented at the ESMO 20th World Congress on Gastrointestinal Cancer 2018 (ESMO-GI) in Barcelona, Spain, June 20 to 23. In addition, Taiho announced that data for TAS-120, the Company’s investigational compound being studied for the potential treatment of patients with cholangiocarcinoma, will be presented.

PRINCETON, N.J., June 7, 2018 – Taiho Oncology, Inc. today announced that, in an effort to further support access for patients and their LONSURF^® treatment, the co-pay for all dose strengths of LONSURF has been reduced from $30 to $0 per treatment cycle. The co-pay reduction, which took effect on May 1, 2018, is available to all patients with commercial prescription insurance coverage for LONSURF.

PRINCETON, N.J., May 9, 2018 – Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), and Servier, announced today that the pivotal Phase 3 (TAGS) trial evaluating LONSURF^® (trifluridine and tipiracil) plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer, met its primary endpoint of prolonged overall survival (OS). These results will be presented at an upcoming medical conference and will be submitted to a peer-reviewed journal for publication.

PRINCETON, N.J., April 13, 2018 – Taiho Oncology, Inc. today announced clinical data for LONSURF^® (trifluridine and tipiracil, TAS-102) for the treatment of patients with advanced gastrointestinal tumors, and two investigational compounds, TAS-120 and TAS-114, both currently in clinical development for the treatment of patients with a variety of advanced solid tumors. These data are being presented at the 109^th Annual Meeting of the American Association for Cancer Research (AACR) in Chicago, April 14 to 18, in McCormick Place South, Exhibit Hall A.

Taiho Oncology Announces Support of Awareness and Research Initiatives to Mark Colorectal Cancer Awareness Month

Taiho Oncology and Servier Present LONSURF^® (trifluridine and tipiracil) Metastatic Colorectal Cancer (mCRC) Data at ASCO 2018 Gastrointestinal Cancers Symposium

Otsuka Signs Statement of Support for Women’s Empowerment Principles

Taiho Oncology Announces Multiple LONSURF^® (trifluridine and tipiracil) Presentations at ASCO 2018 Gastrointestinal Cancers Symposium

Taiho Oncology Names Timothy Whitten President

Health Canada Grants Priority Review Status to trifluridine and tipiracil for Refractory Metastatic Colorectal Cancer

Taiho Pharmaceutical to Participate in Japan Healthcare Venture Summit 2017

Taiho Oncology Inc. Announces Expansion into Canada

Taiho Oncology Announces Multiple Presentations at the ASCO 2016 Annual Meeting

Taiho Oncology, Inc. Announces Comprehensive Access Support Program for LONSURF^® (trifluridine and tipiracil)

Taiho Oncology, Inc. Announces FDA Approval of LONSURF^® (trifluridine and tipiracil) for Refractory Metastatic Colorectal Cancer (mCRC)

Taiho Oncology, Inc. Announces TAS-102 New Drug Application for Refractory Metastatic Colorectal Cancer Accepted for Review by FDA

Taiho Oncology Completes Submission of TAS-102 New Drug Application to the US Food and Drug Administration for the Treatment of Refractory Metastatic Colorectal Cancer

Princeton, NJ – October 20, 2014 – Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer (mCRC), and that the Company has initiated a rolling NDA submission to the FDA.

Taiho Pharmaceutical Co., Ltd.(HQ: Tokyo, President and Representative Director: Masayuki Kobayashi, hereinafter “Taiho”), a fully-fledged oncology pharmaceutical company, announced today that the company will be investing US$ 30 million in Remiges BioPharma Fund (hereinafter “Remiges Fund”), a newly formed biotech venture capital fund.

Princeton, NJ – June 28, 2014 – Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), announced today detailed findings from its global Phase III RECOURSE trial of TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug.

Princeton, NJ – May 12, 2014 – Taiho Oncology, Inc., a division of Taiho Pharmaceutical Co., Ltd. (Japan), today announced the appointment of Tim Whitten to the position of Senior Vice President and Chief Commercial Officer. The appointment of Mr. Whitten represents the initial step in the transition of the company to a more fully integrated clinical development and commercial entity as it prepares for the potential marketing approval of its lead compound, TAS-102, an oral combination anticancer drug (nonproprietary names: trifluridine and tipiracil hydrochloride). Taiho Oncology, Inc. announced earlier today that TAS-102, in the global Phase III RECOURSE trial, met its primary endpoint of demonstrating improvement in overall survival (OS) in patients with refractory metastatic colorectal cancer (mCRC) whose disease had progressed after approved standard therapies.