Taiho Oncology
57 articles about Taiho Oncology
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Boundless Bio Announces Clinical Trial Collaboration and Supply Agreement with Taiho Oncology to Evaluate LYTGOBI® (futibatinib) in Combination with BBI-355 in Patients with FGFR Amplified Solid Tumors
9/18/2023
Boundless Bio Announces Clinical Trial Collaboration and Supply Agreement with Taiho Oncology to Evaluate LYTGOBI ® (futibatinib) in Combination with BBI-355 in Patients with FGFR Amplified Solid Tumors.
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REZILIENT3 Global First-Line Trial of Zipalertinib Launched in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
8/3/2023
Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc., announced today the launch of the REZILIENT3 trial (NCT05973773, Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors).
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The regulator Wednesday approved expanding Lonsurf’s label for previously treated metastatic colorectal cancer, authorizing a combination regimen with Roche’s bevacizumab.
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FDA Approves LONSURF® (trifluridine/tipiracil) in Combination With Bevacizumab for Adult Patients With Metastatic Colorectal Cancer (mCRC)
8/2/2023
Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved LONSURF®.
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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
5/3/2023
Taiho Oncology, Inc. and Servier today announced the publication of results from the pivotal Phase 3 SUNLIGHT* clinical trial of trifluridine/tipiracil (LONSURF®), alone or in combination with bevacizumab, in refractory metastatic colorectal cancer (mCRC) in the May 4, 2023, issue of the New England Journal of Medicine (NEJM).
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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 (mCRC)
4/18/2023
Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental new drug application (sNDA) for trifluridine/tipiracil (LONSURF®) as monotherapy or in combination with bevacizumab.
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Servier and Taiho Oncology announced Tuesday that Lonsurf in combination with bevacizumab improved overall survival rates in patients with refractory metastatic colorectal cancer.
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Taiho Oncology Announces Publication in The New England Journal of Medicine of Pivotal Data for Futibatinib in Previously Treated Patients With Metastatic Intrahepatic Cholangiocarcinoma
1/18/2023
Taiho Oncology, Inc. today announced the publication of results from the pivotal Phase 2 FOENIX*-CCA2 clinical trial of futibatinib in the January 19, 2023 issue of The New England Journal of Medicine (NEJM)
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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
1/17/2023
Servier and Taiho Oncology, Inc., today announced the release of data from SUNLIGHT, a pivotal Phase 3 global trial evaluating the combination of trifluridine/tipiracil (LONSURF®) and bevacizumab in adults with refractory metastatic colorectal cancer (mCRC), demonstrating that the trial met its primary endpoint of overall survival (OS).
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Taiho Oncology and Astex Pharmaceuticals Present Overall Survival Data for Oral Decitabine and Cedazuridine (INQOVI®, ASTX727) in Patients With MDS and CMML Harboring TP53 Mutations at 64th ASH Annual Meeting
12/12/2022
Taiho Oncology, Inc. and Astex Pharmaceuticals, Inc. today announced preliminary data from the Phase 3 ASCERTAIN trial assessing overall and leukemia-free survival in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML) harboring biallelic TP53 mutations following treatment with oral decitabine and cedazuridine (ASTX727).
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The FDA had a fairly quiet week, approving drugs, providing clearance, greenlighting clinical trials, and other regulatory activities for Alnylam, Eli Lilly, Cytokinetics, and more.
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FDA Approves Taiho's LYTGOBI® (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma
9/30/2022
Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration has approved LYTGOBI® tablets for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements.
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Drug Combination Meets Survival Endpoint in Phase III Pivotal Trial Involving Participants With Refractory Metastatic Colorectal Cancer
9/12/2022
Servier, Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd., announced today that the investigational combination of trifluridine/tipiracil plus bevacizumab showed a statistically significant improvement in the primary endpoint of overall survival (OS) compared to trifluridine/tipiracil alone in a Phase III clinical trial of participants with refractory metastatic colorectal cancer (mCRC) following two chemotherapy regimens.
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Taiho Oncology Announces Updated Efficacy and Safety Data for Futibatinib in Cholangiocarcinoma at 2022 ASCO Annual Meeting
6/3/2022
Taiho Oncology, Inc. announced today updated results of the Phase 2 FOENIX-CCA2 trial of futibatinib, confirming results observed in an earlier analysis. The trial was conducted in patients with locally advanced or metastatic unresectable intrahepatic (inside the liver) cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements including fusions.
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U.S. Food and Drug Administration (FDA) Accepts for Priority Review Taiho Oncology's New Drug Application for Futibatinib for Cholangiocarcinoma
3/30/2022
Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for futibatinib.
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Taiho Oncology Recognizes the Important Role of Advocacy Organizations in Marking National Colorectal Cancer Awareness Month
3/1/2022
As part of Colorectal Cancer Awareness Month throughout March, Taiho Oncology, Inc., a company focused on advancing care in colorectal and other cancers, is calling for greater awareness of both the unique challenges faced by patients living with this disease, and of the resources and support required to help patients navigate their journey.
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Taiho Oncology To Share Data in Advanced Solid Tumors at ESMO Congress 2021
9/13/2021
Taiho Oncology, Inc. which specializes in orally administered anti-cancer medicines and whose mission is to improve the lives of patients with cancer, their families and their caregivers, announced data presentations from several studies for two of its investigational agents at the European Society for Medical Oncology Congress 2021.
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Taiho Oncology Announces Presentation of Phase 2 Data for Futibatinib (TAS-120) in Advanced Intrahepatic Cholangiocarcinoma at Virtual AACR Annual Meeting 2021
4/11/2021
Taiho Oncology, Inc. announced efficacy and safety results from the Phase 2 FOENIX-CCA2 trial, a single-arm multicenter Phase 2 study evaluating futibatinib in patients with intrahepatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions who have failed at least one line of therapy.
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Taiho Oncology To Present Phase 2 Data for Futibatinib (TAS-120) in Advanced Intrahepatic Cholangiocarcinoma at Virtual AACR Annual Meeting 2021
4/2/2021
Taiho Oncology, Inc. today announced that Phase 2 clinical data, along with preclinical and Phase 1 clinical data for futibatinib (TAS-120) will be presented during the American Association for Cancer Research (AACR) Annual Meeting 2021 Week 1, taking place virtually from April 10-15, 2021 .
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FDA Grants Breakthrough Therapy Designation for Taiho Oncology's Futibatinib for Treatment of Advanced Cholangiocarcinoma
4/1/2021
Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for futibatinib (TAS-120)