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2018-10-25

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.

2018-10-22

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

2018-10-21

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.

2018-09-28

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.

2018-06-21

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.

2018-06-20

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 20th World Congress on Gastrointestinal Cancer 2018 (ESMO-GI) in Barcelona, Spain, June 20 to 23.

2018-06-14

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.

2018-06-07

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.

2018-05-09

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.

2018-04-13

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 109th Annual Meeting of the American Association for Cancer Research (AACR) in Chicago, April 14 to 18, in McCormick Place South, Exhibit Hall A.

2018-03-08

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

2018-01-20

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

2018-01-19

Otsuka Signs Statement of Support for Women’s Empowerment Principles

2018-01-12

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

2018-01-02

Taiho Oncology Names Timothy Whitten President

2017-10-20

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

2017-10-04

Taiho Pharmaceutical to Participate in Japan Healthcare Venture Summit 2017

2016-11-18

Taiho Oncology Inc. Announces Expansion into Canada

2016-05-31

Taiho Oncology Announces Multiple Presentations at the ASCO 2016 Annual Meeting

2015-09-29

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

2015-09-22

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

2015-02-23

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

2014-12-22

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

2014-10-20

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.

2014-07-23

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.

2014-06-28

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.

2014-05-12

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.

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