The Ministry of health of the Russian Federation approved the application of the first Russian original PD-1 inhibitor progremela for the treatment of one of the most aggressive types of cancer — metastatic or inoperable melanoma. The drug is manufactured by the biotechnology company BIOCAD.
Prolegomena first PD-1 inhibitor, a monoclonal antibody of isotype IgG1 Fc fragment modified by genetic engineering. The mechanism of action of inhibitors of PD-1 directed at restoring the ability of T lymphocytes to recognize and destroy malignant cells, causing a person’s immune system then starts to fight the tumor.
“The development of own competences in this industry, as pharmaceuticals, is one of the most important areas for us. A conclusion to the Russian market original products suggests that domestic manufacturers, scientific research institutes, biotechnology companies, as in the case of SUPPLIES to make this region more competitive and also to develop export potential”, – said the first Deputy Minister of industry and trade of the Russian Federation Sergey Tsyb.
The results of clinical studies of the drug were presented to the company BIOCAD last year. Miraculum sa in the study included 126 patients with unresectable or metastatic melanoma from Russia and Belarus. Complete or partial response to therapy was observed in 48% of patients with melanoma who received Prolegomena in the dosing regimen of 1 mg/kg 1 every 2 weeks as first-line therapy. The majority responded to the treatment response persisted throughout the observation period. 12-month progression-free survival in this group of patients was 44.6%, and overall survival reached 71,8% the study Also showed that the new drug has a favorable safety profile with a low rate of discontinuation of therapy due to adverse events (3.2 percent).