Russia Commences Domestic Manufacturing of Targeted Oncology Agent for Lung Cancer Treatment

Russia Commences Domestic Manufacturing of Targeted Oncology Agent for Lung Cancer Treatment

Russian health authorities have granted market authorization to Alectinib-Amedart, a domestically manufactured therapeutic designed to provide a more cost-effective and accessible alternative to the originator product Alecensa (alectinib, Roche). Alectinib represents a critical treatment option for patients with non-small cell lung cancer harboring specific genetic alterations.

News

Jan 21, 2026

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Photo Source: Amedart

 

The Russian pharmaceutical manufacturer Amedart produces the drug utilizing active pharmaceutical ingredient (API) sourced from Hetero Labs Limited, an Indian pharmaceutical company.

 

The per-package cost of the Russian generic is 40% lower than the Roche product: 572 rubles versus 954 rubles. This substantial price reduction is anticipated to significantly enhance drug accessibility both within the state-funded pharmaceutical provision system and for patients accessing treatment through fee-for-service arrangements, including international patients seeking care in Russia.

 

Alectinib is recognized as one of the most advanced and efficacious targeted therapies available for non-small cell lung cancer with ALK gene translocation in patients presenting with locally advanced or metastatic disease. This therapeutic agent is incorporated into first-line treatment protocols for ALK-positive NSCLC according to all major international and Russian clinical practice guidelines, including those published by the National Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO), and the Russian Society of Clinical Oncology (RUSSCO).

 

Based on lung cancer epidemiological data in Russia, alectinib therapy may be indicated for approximately 4-5% of all NSCLC patients, translating to an estimated patient population of 2,000-2,500 individuals annually.

 

Previously, Marus Media reported the initiation of clinical trials in Russia for the investigational oncology agent OM-RCA-01, the world's first selective inhibitor of the fibroblast growth factor receptor 1 (FGFR1). This receptor protein plays a role in the proliferation of several malignancy types. The development of OM-RCA-01 and its potential clinical applications were discussed in an exclusive interview with Marus Media by Dr. Ilya Timofeev, Director of the Autonomous Non-Profit Organization "Bureau for Cancer Research" (BUCARE), practicing oncologist, and member of the scientific committee of the European School of Oncology College (ESCO).

 

Source: Federal Antimonopoly Service of Russia

 

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