09/10/2026
Armenia has officially become the first country in the world to grant marketing authorizations for Agenus’ innovative immunotherapy combination botensilimab and balstilimab (BOT+BAL). Issued by the Ministry of Health, this milestone decision marks the first global approval for either medicine, establishing an important precedent for advanced cancer care.
The conditional approvals cover their combined use in adult patients with microsatellite-stable (MSS) metastatic colorectal cancer without active liver metastases who have previously received standard available therapies. Marketed in Armenia under the brand names Botvymo (botensilimab) and Evamplix (balstilimab), this regimen offers a much-needed treatment path for local patients as well as those traveling to Armenia for specialized oncological care.
Backed by robust clinical data from Phase 1b and Phase 2 studies published in leading peer-reviewed journals like Nature Medicine and Clinical Cancer Research, this regulatory clearance transitions the therapy from clinical development into authorized use. Beyond Armenia, Agenus will evaluate potential applications across Eurasian Economic Union member countries, reinforcing the combination's global impact in oncology.