Having met the primary endpoint of overall survival in it's Phase III trial of TAS-102 for refractory metastatic CRC, Taiho plans regulatory submissions.
Taiho Pharmaceutical Co., Ltd. (Tokyo, Japan) and its division Taiho Oncology, Inc. (Princeton, N.J.) announced on May 12 results from its global Phase III RECOURSE trial on its oral combination anticancer drug TAS-102 (nonproprietary names:trifluridine and tipiracil hydrochloride) in refractory metastatic colorectal cancer (mCRC). The RECOURSE trial met its primary endpoint of demonstrating improvement in overall survival (OS) in patients with refractory mCRC whose disease had progressed after approved standard therapies.
"We are very pleased by the results from the Phase III RECOURSE trial in refractory mCRC, which support TAS-102 as a potential new treatment option for this patient population," said Fabio M. Benedetti, M.D., Senior Vice President and Chief Medical Officer at Taiho Oncology. "The Taiho Oncology team is preparing for the submission of the NDA and MAA of TAS-102 in the United States and the , respectively. We would like to thank our clinical investigators and healthcare professionals, as well as the patients and caregivers, for their participation in this important trial."
Source of the PR: MarketWatch