5 News & Press Releases found

Taiho Oncology, Inc. news

FDA Approves Taiho’s LYTGOBI® (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma

LYTGOBI (pronounced “light-GOH-bee”) delivered an objective response rate of 42% and median duration of response of 9.7 months in the primary analysis of the pivotal clinical trial.
LYTGOBI covalently binds to FGFR2 and inhibits the signaling pathway. The other approved FGFR inhibitors are reversible ATP-competitive inhibitors.
LYTGOBI previously received breakthrough, orphan drug and p

Sep. 30, 2022

Drug Combination Meets Survival Endpoint in Phase III Pivotal Trial Involving Participants With Refractory Metastatic Colorectal Cancer

Results from the primary analysis of the SUNLIGHT trial to be presented at an upcoming scientific conference

Paris - September 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 clin

Sep. 12, 2022

Taiho Oncology Announces Updated Efficacy and Safety Data for Futibatinib in Cholangiocarcinoma at 2022 ASCO Annual Meeting

PRINCETON, N.J., June 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) harboringFGFR2 gene rearrangements including fusions. These data were presented as an oral presentation at the 2022 American Society of Cli

Jun. 3, 2022

Cullinan Oncology and Taiho Pharmaceutical Announce Strategic Collaboration to Jointly Develop and Commercialize CLN-081/TAS6417 and Taiho’s Acquisition of Cullinan Pearl

Taiho obtains exclusive global rights to CLN-081/TAS6417 outside the U.S.; in the U.S., Taiho and Cullinan Oncology to jointly develop and co-commercialize CLN-081/TAS6417

Cullinan Oncology will receive an upfront cash payment of $275 million, with potential to receive up to an additional $130 million in regulatory-based milestone payments

Cullinan Oncology and Taiho will equally share future profits in the U.S.

May. 12, 2022

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Taiho Oncology’s New Drug Application for Futibatinib for Cholangiocarcinoma

PRINCETON, N.J., MARCH 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 in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboringFGFR2 gene rearrangements, including gene fusions. Futibatinib is an investigational, oral, potent, selective and i

Mar. 30, 2022