FDA Grants Fast Track Designation To Taiho's TAS-102 In Colorectal Cancer
By Cyndi Root
Taiho Oncology announced that the Food and Drug Administration (FDA) has granted TAS-102 (trifluridine and tipiracil hydrochloride) Fast Track designation. The company issued the announcement in a press release, stating that it has initiated a rolling New Drug Application (NDA) for the oral treatment of refractory metastatic colorectal cancer (mCRC). The Fast Track designation earns Taiho expedited review.
Fabio Benedetti, Senior VP and CMO at Taiho Oncology, said, “Patients with metastatic colorectal cancer, whose disease has progressed after treatment with standard therapies, have limited treatment options to manage their disease.”
TAS-102
TAS-102 is an oral combination of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog that interferes with DNA function by directly penetrating the DNA. TPI inhibits the FTD-degrading enzyme, thymidine phosphorylase, thereby maintaining FTD blood concentration. Taiho is supporting its FDA application with the Phase 3 RECOURSE trial of TAS-102 in 800 patients with mCRC, who are intolerant to standard therapies or whose disease had progressed. Results from the trial were presented at the 16th ESMO World Congress on Gastrointestinal Cancer and published in the Annals of Oncology
The European Society for Medical Oncology commented on the results in a June 2014 press release. ESMO spokesperson Jean Yves Douillard, professor of medical oncology in France, said, “The phase 3 trial of TAS-102 is a global study and confirms the results of the phase 2 study in Japanese patients, whose response to fluoropyrimidine is slightly different to patients in Europe and the U.S. It is good to know that the magnitude of benefit shown in the smaller phase 2 trial is confirmed in the larger phase 3 trial and that the results apply to Asians and Caucasians alike.” He also said that he would recommend TAS-102 as an early treatment combined with either irinotecan or oxaliplatin.
About Taiho Oncology
Taiho Oncology is a subsidiary of Taiho Pharmaceutical and Otsuka. The company focuses on oncology treatments consisting of oral anti-metabolic agents. The company released Futraful (tegafur) in 1974 and its products include UFT (tegafur uracil) and TS-1 (tegafur, gimeracil, oteracil potassium).