Vamotinib is about to be registered and put into civil circulation by Pharmasyntez, a Russian pharmaceutical company that aims to provide Russian patients with access to new and innovative medications. The first fully developed and produced in Russia third-generation tyrosine kinase inhibitor (TKI) Vamotinib is a powerful and highly selective TKI used to treat patients with chronic myeloid leukemia (CML) who have not responded to prior treatments.

Vikram Punia, President of the Pharmasyntez Group, stated:

“I see no other way for the development of Pharmasyntez and the entire pharmaceutical industry of the country, except for the development and production of innovative medicines. The Pharmasyntez Group has made the decision to only pursue innovative approaches for future development after realizing that only these approaches can initially offer patients safer and more effective treatment. The company is constantly creating new and inventive medications as part of its strategy. We will introduce two novel medications to the market this year that will have a big impact on the patient care standard. Vamotinib is one of such medications used to treat chronic myeloid leukemia. Since Vamotinib has a better safety profile than any other medication currently used to treat CML, and its introduction will greatly advance the treatment of this disease. This development has cost Pharmasyntez billions of rubles and roughly seven years. Patients with chronic myeloid leukemia will now be able to live decades with the disease in a way that is safer and more comfortable than ever before, thanks to our efforts and investments, I am sure of it!”

Chronic myeloid leukemia represents a rare and dangerous blood tumor disease originating from a genetic breakage, when segments of chromosomes 9 and 22 abnormally swap places, resulting in the Philadelphia chromosome in a hematopoietic precursor cell, and cause uncontrolled tumor cell proliferation and leukemia. In Russia, approximately 1,000 new CML cases emerge annually, accounting for 15% of all adult leukemia diagnoses. The disease displays a cruel predilection for targeting adults in their prime - with the majority of cases striking between ages 50-60, just as patients typically reach peak professional achievement and social engagement.¹

Before the advent of tyrosine kinase inhibitors, a diagnosis of chronic myeloid leukemia sounded like a death sentence — most patients survived just 3 to 5 years. That all changed in 2001 with the introduction of Imatinib, the first-generation TKI that revolutionized CML treatment. About 90% of patients with CML survive for decades thanks to the development of first-generation TKIs and later second-generation TKIs (dasatinib, nilotinib, and bosutinib) in clinical practice.²

Although tyrosine kinase inhibitors have made breakthroughs in the treatment of CML, resistance occurs in 25% of patients, which is linked to either absence or inadequate response or loss of the therapy's effectiveness over time.³

Since patients with CML take TKIs in a continuous regimen, allowing for disease control, it is crucial to guarantee patient safety during treatment and to avoid serious, potentially fatal complications. In addition to the development of resistance in the treatment of CML, intolerance and safety of TKIs represent a significant unresolved medical issue.

There seem to be notable variations in the safety of TKIs. The different TKIs show distinct, drug-specific kinds of complications in addition to a general toxicity profile that includes hematologic and skin toxicity. Pleural effusion, pulmonary hypertension, cardiovascular problems, hepatotoxicity, arterial occlusive lesions, elevated blood glucose, pancreatitis, and dyspeptic phenomena (diarrhea, nausea, vomiting) are some examples of specific toxicity types. The development of adverse events has a substantial impact on the length and quality of life for patients with CML. At this point in CML treatment, ensuring safe therapy becomes a top priority.³

According to the results of Phase I and Phase III clinical trials, Vamotinib is highly effective and has a high specific safety profile, including cardiovascular safety, making it a promising solution for patients who are resistant to or intolerant of previous treatments.⁴

Vamotinib, an oral tyrosine kinase inhibitor was developed in Russia for the treatment of chronic myeloid leukemia in patients who are resistant to previous treatments, including those with the T315I mutation⁴.

Phase III clinical trials are presently being conducted on the medication to verify its safety and efficacy in a larger patient population. The interim analysis's results attest to its excellent safety profile and high efficacy.

Since Vamotinib was developed in the Russian Federation, there is less dependence on foreign analogs. It is a significant accomplishment for the Russian pharmaceutical industry, because it has the potential to enter the global market. Vamotinib's introduction to the market will guarantee that Russian patients can access effective treatment and will mark a major advancement in the fight against chronic myeloleukemia.

1. Туркина А.Г., Новицкая Н.В., Голенков А.К. и др. Регистр больных хроническим миелолейкозом в Российской Федерации: от наблюдательного исследования к оценке эффективности терапии в клинической практике. Клиническая онкогематология. 2017;10(3):390–401./ A.G.Turkina, et al. Register of patients with chronic myeloleukemia in the Russian Federation: from observational study to assessment of therapy efficacy in clinical practice. Clinical Oncohematology 2017;10(3):390–401

2. Tariq I. Mughal, Jerald P. Radich, Michael W. Deininger Chronic myeloid leukemia: reminiscences and dreams, Heamatologica, Vol. 101 No. 5 (2016): May, 2016, p.541-558

3. Ломаиа Е.Г. Романова Е.Г., Сбитякова Е.И., Зарицкий А.Ю. Эффективность и безопасность ингибиторов тирозинкиназ 2-го поколения (дазатиниб, нилотиниб) в терапии хронической фазы хронического миелолейкоза. Онкогематология. 2013; 2: 22-33./ Ye.G. Lomaia, et al. Efficacy and safety of 2nd generation tyrosine kinase inhibitors (dasatinib, nilotinib) in the therapy of chronic myeloleukemia chronic phase. Oncohematology 2013; 2:22-33

4. Туркина А. Г., Виноградова О. Ю., Ломаиа Е. Г. PF-114 - ингибитор BCR-ABL: основные результаты клинического исследования 1-й фазы у пациентов с ХМЛ с резистентностью и непереносимостью ингибиторов 2-го поколения или с мутацией Т315I. гематология и трансфузиология. | 2020; ТОМ 65; №1: 50. |/ A.G. Turkina, et al. PF-114, a BCR-ABL inhibitor: key results from a phase I clinical trial in CML patients with resistance and intolerance to 2nd generation inhibitors or with a T315I mutation. Hematology and TransfusiologyHematology and Transfusiology 2020;65(1):50