Armenia has become the first country in the world to authorize the use of two experimental anti-cancer drugs developed by the American company Agenus. The combination therapy is intended for adult patients with a specific form of colon or rectal cancer who have not responded to standard treatment and do not have active liver metastases. The company announced this on October 8.

The drugs are named Botvymo (botensilimab) and Evamplix (balstilimab). They are classified as immunotherapies—treatments that help the immune system recognize and attack tumors. Because the drugs target different immune defense mechanisms, they are used in combination.

The treatment targets microsatellite-stable (MSS) cancer. Such tumors typically respond less effectively to common forms of immunotherapy than other types of colorectal cancer. This new combination aims to help patients who have limited treatment options.

The authorizations granted by Armenia’s Ministry of Health took effect on October 2, 2026, and are valid for one year. They may be renewed upon the submission of additional clinical data. Treatment will be available to both Armenian citizens and foreign nationals who have traveled to Armenia and are under the care of local oncologists.

The decision is based on the results of several clinical studies, including Phase 1 and Phase 2 trials. The Phase 1 study (C-800-01) involved 123 patients. Published results show a median overall survival of 21.2 months. This figure indicates that half of the participants lived longer than this period, while the other half lived for a shorter time. Study results do not guarantee the same outcome for every patient. Approval for use does not mean that the drugs are free from serious side effects. Immunotherapy can trigger inflammatory reactions affecting the intestines, liver, lungs, and endocrine system; therefore, treatment requires medical supervision.

Agenus intends to explore the possibility of registering the drugs in other countries of the Eurasian Economic Union as well.