Armenia has become the first country in the world to grant marketing authorizations for Agenus’ cancer drugs Botvymo (botensilimab) and Evamplix (balstilimab), for use in adults with previously treated microsatellite stable (MSS) metastatic colorectal cancer (mCRC).

 

The approvals, effective October 2, 2026, mark a significant regulatory milestone for Agenus Inc. and could open a new treatment option for patients whose disease has progressed despite available standard therapies.

 

The Armenian Ministry of Health granted separate marketing authorizations for the two medicines, specifically for use together. The company said the approvals are the first anywhere in the world for either drug.

 

The decision is expected to benefit patients in Armenia and those travelling to the country for treatment under the care of Armenian oncologists.

 

“Armenia is the first country in the world to grant marketing approval for BOT+BAL,” said Garo H Armen, Chairman and Chief Executive Officer of Agenus. 

 

“The evidence behind this decision has been published in peer-reviewed journals and presented at major cancer conferences, and it has consistently pointed to clinical benefit for patients with metastatic colorectal cancer. We thank Armenia’s health authorities for the depth and care of their review. Patients who have exhausted standard treatments now have a new option, and we are proud to bring it to them.”

 

The approvals followed a review by Armenian regulatory authorities of Agenus’ registration dossier, submitted in the international Common Technical Document format used under Eurasian Economic Union rules.

 

The assessment covered manufacturing and product quality, nonclinical research, clinical efficacy and safety, as well as pharmacovigilance and risk-management measures.

 

The regulatory decision was supported by clinical evidence from the Phase 1b C-800-01 study, including two-year survival findings, and the randomized Phase 2 C-800-25 study. The evidence covered patients with MSS metastatic colorectal cancer, including those without active liver metastases.

 

Results from the clinical programme have been published in peer-reviewed journals, including Nature Medicine and Clinical Cancer Research, and presented at major oncology meetings, including the ASCO Gastrointestinal Cancers Symposium.

 

 

Botensilimab is a multifunctional, Fc-enhanced anti-CTLA-4 antibody designed to stimulate both innate and adaptive antitumour immune responses, including in cancers that have historically responded poorly to conventional immunotherapy.

 

Balstilimab is an anti-PD-1 antibody designed to sustain the activity of T cells against tumours.

 

Under the approved product information, Botvymo is administered intravenously at 75 mg every six weeks for up to four doses. Evamplix is administered intravenously at 240 mg every two weeks for up to two years, or until disease progression or unacceptable toxicity.

 

The authorizations are conditional, valid for one year and renewable based on annual clinical updates that Agenus must provide to Armenian regulators.

 

 

With Armenia opening the way, Agenus plans to evaluate potential marketing authorization applications for BOT+BAL in other Eurasian Economic Union member countries for the same patient population.

 

The company has not announced approvals in any other countries. Further expansion will depend on regulatory pathways and reviews in individual markets.

 

For now, Armenia’s decision represents the first regulatory clearance worldwide for the BOT+BAL combination in this setting, bringing the treatment into a new phase beyond clinical research and into potential patient access.