The drug Apalutamide-Promomed for the treatment of prostate cancer has entered the Russian market

PROMOMED Company announces the launch on the Russian market of Apalutamide-Prommed, the first domestic second–generation androgen receptor inhibitor for the treatment of metastatic hormone-sensitive prostate cancer (mGCRPC) and nonmetastatic castration-resistant prostate cancer (NMCRPC).

Prostate cancer is a serious social problem. In 2023, it reached the 1st place in Russia in terms of the prevalence of cancer in men and the 3rd place among the causes of death from cancer.

The presentation of Apalutamide-Promomed for the professional community took place within the framework of the XI St. Petersburg International Cancer Forum "White Nights 2025".

Maria Volkova, MD, Professor at the A. I. Savitsky Department of Oncology and Palliative Medicine of the Russian Ministry of Health, noted that the advent of second-generation antiandrogens has opened up new prospects in the treatment of prostate cancer, significantly improving the results of drug therapy. One of the representatives of this class of drugs is apalutamide, which inhibits prostate tumor growth by blocking androgen binding to receptors and preventing these receptors from binding to DNA, which reduces the expression of genes necessary for tumor growth.

Boris Alekseev, MD, Professor, Corresponding Member of the Russian Academy of Sciences, Deputy Director General for Science of the National Research Medical Center of Radiology of the Ministry of Health of the Russian Federation, concluded that timely inclusion of apalutamide in the treatment regimens of MHD significantly increases overall survival. The TITAN study proved that the combination of apalutamide with androgen deprivation therapy reduces the risk of death by 35%. Patients live years longer without progression, maintaining their quality of life due to a favorable tolerance profile. The SPARTAN study confirmed the ability of apalutamide to significantly delay metastasis and prolong life as a first-line therapy in patients with NSCLC.

Irina Vashkina, Director of marketing and sales at the PROMOMED Group's budget channel, stressed that treatment with modern antiandrogens involves significant costs: in 2024 alone, almost 23 billion rubles were allocated for this. Due to the high cost of foreign drugs, not all patients can receive the necessary treatment in a short time. The introduction of the domestic drug Apalutamide-Promomed into clinical practice is an important step providing Russian patients with access to advanced treatment methods. The cost of Apalutamide Promomed is 40% lower compared to foreign second-generation antiandrogens, which helps save budget funds, reduces dependence on imports and allows for wider use of innovative approaches, giving thousands of patients a chance to receive the most modern therapy.

Kira Zaslavskaya, Director of New products at PROMOMED Group, emphasized that Apalutamide-Promomed is produced in accordance with GMP standards at the domestic Biochemik enterprise in a full cycle – from the production of the substance (active ingredient) to the production of the finished dosage form (tablets) and final packaging. The complete localization of the production of Apalutamide-Promomed is a significant contribution to the implementation of the strategy to ensure drug safety in the Russian Federation.

Information sources
1. The State Register of Medicines
2. Malignant neoplasms in Russia in 2023
3. FAS of Russia
4. Titan: Kim N. Chi et al, Journal of Clinical Oncology 39, no. 20 (July 10, 2021) 2294-2303.DOI:10.1200/JCO.20.03488.
5. SPARTAN: Small E., Lee J.,Lopez-Gitlitz A. Prostate-Specific Antigen Outcomes in Patients With Nonmetastatic Castration-Resistant Prostate Cancer Treated With Apalutamide:Results from the Phase 3 SPARTAN Study. American Urological Association Annual Meeting; 18-21 May, 2018 DOI: 10.1016/S1470-2045(18)30456-X
6. Unified Information System of Procurement