The First Russian Drug for The Melanoma Treatment Was Released 28.07.2020161

03 August 2020

GMP News

In July 2020, Russian pharmacies and hospitals received the first domestic original drug intended for the treatment of melanoma — PD-1 inhibitor Prolgolimab. The drug was approved by the Ministry of Health of the Russian Federation for the treatment of one of the most aggressive types of cancer — metastatic or inoperable melanoma — at the end of April this year. Prolgolimab restores the ability of the human body’s immune system to fight a tumor. The inhibitor is developed and manufactured by the biotechnological company BIOCAD.

The drug will be available for national and regional hospitals; and will be sold in pharmacies. The inclusion of the drug in the list of Essential Medicines List is expected in early 2021, which will reduce the burden on the budget.

“Cancer is a problem that can come to any family,” says Dmitry Morozov, CEO of the biotechnological company Biocad, “especially when it comes to one of the most insidious types of disease — skin melanoma. In April, we registered a drug for the treatment of this disease, and in July it became available to patients.”

The head of the company recalled that Prolgolimab is the world’s first PD-1 inhibitor based on IgG1 monoclonal antibodies with additional modifications of its effector properties. In the human body, malignant cells are formed daily, destroyed by immune mechanisms before the tumor grows enough to become a threat to health. The tumor cell eludes the immune response by masquerading as a normal cell, which leads to its growth. PD-1 inhibitors activate T-lymphocytes and allow them to recognize and destroy malignant cells, the immune system begins to fight the tumor again.

Before the introduction of a Russian inhibitor, the market for skin melanoma therapy in Russia was monopolized by Nivolumab and Pembrolizumab. According to Headway Company these American drugs were third and fourth by sales volume in 2019. The total value of contracts for Nivolumab was 2,375,1 million rubles and 1,854,8 million rubles for Pembrolizumab for the first six months of 2019 in Russia. The introduction of a new drug to the market and its inclusion in the Essential Medicines List will reduce the burden on the budget.

Due to the spread of coronavirus infection, many patients with cancer can not receive surgical treatment. The introduction of modern approaches to the treatment of cancer patients is especially important now. At the recent International Council of experts on cancer care, representatives of BIOCAD stressed the importance of consolidating the efforts of doctors and businesses to overcome the current situation. The market access of a domestic inhibitor is particularly important during the pandemic.

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