Management on quality control of foodstuff and medicines of the USA (FDA) dilated indications to use of a medicinal preparation regorafinib, having included treatment of patients with a hepatocellular carcinoma (GTsR) who underwent therapy sorafenib earlier. It is the first approved FDA drug for cancer therapy of a liver honor in ten years, it is told in the report of the American regulator.
Safety and efficiency of a regorafenib was studied within randomized clinical trial with participation of 573 patients from GTsR progressing against the background of reception of a sorafenib. Experts considered indicators of the general survival of patients, survival without advance of a disease and cooperative efficiency of therapy. Results showed that average general survival of the patients accepting регорафениб made 10,6 months in comparison with 7,8 months in group of placebo. Survival without advance of a disease – 3,1 months and 1,5 months respectively. Cooperative efficiency of therapy made 11%, in group of placebo – 4%.
Abdominal pains, palmar and plantar syndrome, fatigue, diarrhea, loss of appetite, hypertonia, dysphonia, hyperbilirubinemia, temperature were the general collateral reactions at treatment regorafeniby, mukozit, loss of weight, an eruption and nausea. Reception of a regorafenib is bound to serious risks of development of a hepatotoxic, an infection, a hemorrhage, gastrointestinal perforation, coronary heart disease and a syndrome of a reversible back leukoencephalopathy.
Reception of a regorafenib isn't recommended to pregnant women and the feeding women, is emphasized in the statement of FDA.
The medicinal preparation регорафениб was approved for treatment of patients earlier with a colorectal cancer or a gastrointestinal stromalny tumor which don't react to the existing standard methods of treatment any more.
Medicines regorafinib and sorafenib are registered in the Russian Federation (data of http://grls.rosminzdrav.ru).