Regorafenib Received Approval Following FDA Japan

Regorafenib (Stivarga, Bayer) is approved by the Japanese Ministry of Health, Labour and Welfare for the treatment of patients with metastatic colorectal cancer (MCRC).

This approval is based on the CORRECCT study of the administration of Regorafenib or placebo following failure of standard treatment for colorectal cancer.) This study compared the efficacy of regorafenib combined with optimal supportive care and placebo in optimal supportive care of patients with metastatic colorectal cancer after disease progression with standard approved therapy. As the results of the regorafenib group showed improvement in patient survival, the study was terminated prematurely.

The multicenter CORRECT study involved 20 units in Japan, the company noted.

In September 2012, regorafenib was approved by the U.S. for chemotherapy based on fluorouracil, oxaliplatin, irinotecan, anti-VEGF therapy, and metastatic colorectal cancer treated with anti-EGFR treatment in patients with wild-type KRAS. Cancer patients.