Japanese approval next for Fruzaqla

Takeda (TYO: 4502) has announced the Japanese approval of Fruzaqla (fruquintinib) capsules 1mg/5mg, a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy.

The approval is based primarily on the results of the FRESCO-2 trial, a global Phase III trial conducted in the USA, Europe, Japan and Australia which met all primary and key secondary efficacy endpoints.

Takayuki Yoshino, deputy director of hospital, head, Division for the Promotion of Drug and Diagnostic Development, and chief, Department of Gastrointestinal Oncology at the National Cancer Center Hospital East, who served on the FRESCO-2 study Steering Committee, said: “Although the mortality rate of CRC has been going down in recent years due to early screening and advances in treatment, the five-year survival rate for metastatic CRC remains low and new treatment options are much in need.