Taiho put on Fast Track in mCRC
The Taiho Oncology Inc. subsidiary of Taiho Pharmaceutical Co. Ltd. (Tokyo, Japan) said FDA has granted Fast Track designation for its TAS-102 to treat refractory metastatic colorectal cancer (mCRC) and that the company has started a rolling NDA submission to the agency.
TAS-102 is an oral formulation of the antineoplastic nucleoside analog trifluridine combined with tipiracil hydrochloride, an inhibitor of the FTD-degrading enzyme thymidine phosphorylase. In March, it was approved in Japan under the name Lonsurf to treat unresectable advanced or recurrent colorectal cancer refractory to standard therapies based on data from a Japanese Phase II trial. The U.S. submission is based on the Phase III RECOURSE trial of the compound in 800 patients with mCRC. ...