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The Ministry of Health of Russia authorizes a Russian anti-melanoma originator

The Ministry of Health of the Russian Federation has authorized a Russian originator drug for the treatment of unresectable or metastatic melanoma. The product was developed by BIOCAD, a biotechnology company; it is a fixed dose combination of two monoclonal antibodies, nurulimab and prolgolimab.

The product will be marketed under the trade name Nurdati®. It is based on a 1:3 fixed dose combination of originator anti-CTLA-4 (nurulimab) and anti-PD-1 (prolgolimab) monoclonal antibodies. The product enhances the immune system capability of combating the tumor.  Combining nurulimab and prolgolimab in the product promotes T cell activation at various stages of the immune response so they are able to recognize and destroy malignant cells. In other words, antitumor immunological surveillance is triggered and the body starts fighting against the malignant neoplasm.

“Authorization of the originator product expands the range of treatment options currently available to patients with unresectable and metastatic melanoma. The combination of two antibodies targeting the release and activation of T cells in one immunotherapeutic anti-cancer product makes it possible to achieve a synergistic effect that can result in an enhanced antitumor immune response,” said Yulia Linkova, Vice President of Research and Development at BIOCAD.

The full range of physicochemical and non-clinical studies were conducted for the product in compliance with the Russian and international standards.  The combination product Nurdati® showed its high efficacy with an acceptable safety profile in Phase II OBERTON clinical trial in patients with unresectable or metastatic melanoma. Based on these findings, the product was authorized following the conditional authorization procedure* provided for by Resolution No. 78 of the EEC Council, On the Rules for Authorization and Expert Evaluation of Medicinal Products for Human Use. The Phase III OCTAVA clinical trial is currently being completed, and its findings are expected to verify the results of the OBERTON trial. BIOCAD investments in the development and research of the product exceeded 1 billion rubles (app. USD 11mln).

To date, melanoma is one of the most aggressive malignancies known. More than 12,000 patients a year are diagnosed with melanoma in Russia, and in recent years the incidence statistics have only been growing. The expert estimate of the metastatic melanoma therapy market in the country is over 21 billion rubles (app. USD 231mln).

“The clinical trial results of using a fixed dose combination of nurulimab and prolgolimab followed by prolgolimab monotherapy may suggest that this approach has the potential to occupy an important niche in the treatment of patients with metastatic or unresectable melanoma,” added Lev Demidov, oncologist (MD, DSc Med.), Professor, Head of the Oncodermatology and Biotherapy Department at the N. N. Blokhin Russian Cancer Research Center, and Chairman of the Board of the Melanoma.PRO Russian Melanoma Professional Association.

Currently, a comparative trial of Nurdati® versus standard treatment for resectable stage III melanoma is ongoing. BCD-217-3/NEO-MIMAJOR trial started in summer 2023; based on its findings, treatment efficacy at earlier stages of the disease may prove to be higher and the product indications may be extended. It is assumed that the therapeutic approach under study will not only significantly reduce the scope of the standard surgical intervention and thereby improve the quality of life of patients following radical therapy, but also make it possible to achieve long-term remission without signs of the disease for many years.


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