Regorafenib Proves to Show Additional Benefits


Regorafenib is a formidable treatment for colon cancer, and in late 2013 it has received another new approval for GIST in Japan and Europe. Known as the trade name Stivarga, Regorafenib was approved in both Japan and Europe for the treatment of gastrointestinal stromal tumors. The FDA approved Regorafenib two years ago and added the gastrointestinal stromal tumor {GIST} indication last February. In mid-January 2014 the Institute for Quality and Efficiency in Health Care {IQWiG} announced small, but substantial benefits of Regorafenib for the treatment of metastatic colorectal cancer. Best supportive care {BSC} as comparator therapy versus Regorafenib was the basis of the data for IQWiG’s recent statement regarding Stivarga. Information gleaned from a pivotal trial in which patients with unresectable colon cancer received either BSC and a placebo or Stivarga {Regorafenib} was encouraging. The IQWiG deemed that the patients who were administered Regorafenib demonstrated statistically sizable improvements in Overall Survival statistics, as compared with the comparator.

Regorafenib-CAS-755037-03-7

Patients who received Regorafenib reported adverse effects such as fatigue, weight loss, nausea, appetite loss and hypertension. The recommended dose and schedule for Regorafenib is 160 milligrams in the form of four 40 milligram tablets once daily by mouth. The medication regimen is usually continued for 21 days out of a 28-day cycle. The patent for Stivarga {Regorafenib} expires for Bayer on January 12, 2020, opening the pathways for continued development of generic formulations of this anti-cancer powerhouse.

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