The Ministry of Health of the Republic of Armenia has granted marketing authorisations for Agenus’ Botvymo (botensilimab, BOT) and Evamplix (balstilimab, BAL), each approved for use in combination with the other for the treatment of adult patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases who have previously received available standard therapies.
These are the first marketing authorisations for either medicine anywhere in the world. The approvals are expected to benefit patients in Armenia as well as patients who travel to Armenia for treatment under the care of Armenian oncologists.
Botensilimab is a multifunctional, Fc-enhanced anti-CTLA-4 antibody designed to activate innate and adaptive antitumor immune responses, including in tumours that have historically responded poorly to conventional immunotherapy. Balstilimab is an anti-PD-1 antibody designed to sustain antitumor T-cell activity.
The approvals were effective as of October 2026. They follow a rigorous review by Armenia’s regulatory authorities of the complete registration dossier, submitted in the international Common Technical Document format used under Eurasian Economic Union rules. The review covered product quality and manufacturing (chemistry, manufacturing and controls), non-clinical data, clinical efficacy and safety data, and the pharmacovigilance system and risk management plan.
