Apalutamide-PROMOMED for the Treatment of Prostate Cancer Launched on the Russian Market
PROMOMED announces the launch of Apalutamide-Promomed, the first domestic second-generation androgen receptor inhibitor for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC), on the Russian market.
Prostate cancer is a major social issue. In 2023, it ranked first among oncological diseases in men in Russia and third among cancer-related causes of death.
The professional community was introduced to Apalutamide-Promomed during the XI St. Petersburg International Oncology Forum “White Nights 2025.”
Prof. Maria Volkova, MD, PhD, Department of Oncology and Palliative Medicine named after A. I. Savitsky, Russian Medical Academy of Continuous Professional Education, Ministry of Health of Russia, emphasized that the advent of second-generation antiandrogens has opened new perspectives in prostate cancer treatment, significantly improving therapeutic outcomes. Apalutamide, one of the representatives of this drug class, suppresses prostate tumor growth by blocking androgen binding to receptors and preventing these receptors from binding to DNA, thereby reducing the expression of genes necessary for tumor growth.
Prof. Boris Alekseev, Doctor of Medical Sciences, Corresponding Member of the Russian Academy of Sciences, Deputy Director General for Science, National Medical Research Radiology Center, Ministry of Health of Russia, concluded that timely inclusion of apalutamide in treatment regimens for mHSPC substantially increases overall survival. The TITAN study demonstrated that the combination of apalutamide with androgen deprivation therapy reduces the risk of death by 35%. Patients live years longer without disease progression, maintaining quality of life thanks to a favorable tolerability profile. The SPARTAN study confirmed apalutamide’s ability to significantly delay metastasis and extend survival as a first-line therapy for nmCRPC patients.
Irina Vashkina, Marketing and Sales Director in the Public Segment, PROMOMED Group, emphasized that treatment with modern antiandrogens is associated with significant costs: in 2024 alone, almost RUB 23 billion was allocated. Due to the high cost of imported drugs, not all patients can access the necessary therapy promptly. The introduction of domestically produced Apalutamide-Promomed is an important step in providing Russian patients with access to advanced treatment options. The price of Apalutamide-Promomed is 40% lower compared to foreign second-generation antiandrogens, contributing to budget savings, reducing dependence on imports, and enabling wider application of innovative approaches, thus giving thousands of patients a chance to receive state-of-the-art therapy.
Kira Zaslavskaya, Director of Novel Products, PROMOMED Group, stressed that Apalutamide-Promomed is manufactured in compliance with GMP standards at the domestic enterprise Biokhimik, following a full-cycle process — from production of the active pharmaceutical ingredient to manufacturing the finished dosage form (tablets) and final packaging. Full localization of Apalutamide-Promomed production is a significant contribution to the implementation of the national strategy for ensuring pharmaceutical security of the Russian Federation.
References
1. State Register of Medicines
2. Malignant Neoplasms in Russia in 2023
3. Federal Antimonopoly Service 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 Procurement Information System (EIS Zakupki)
