Agenus has received its first-ever marketing authorisations for botensilimab, branded as Botvymo, and balstilimab, branded as Evamplix, from the Ministry of Health of the Republic of Armenia. Both medicines are approved for use in combination to treat adults with previously treated Microsatellite-Stable (MSS) metastatic Colorectal Cancer (mCRC) without active liver metastases.

The authorisations, effective October 2, 2026, mark the first marketing approvals for either medicine worldwide. The approvals are conditional, valid for one year and renewable based on annual clinical updates submitted by Agenus to Armenia’s regulatory authorities.

The medicines were reviewed separately and approved for use as a combination regimen following an assessment of their registration dossiers submitted in the international Common Technical Document format under Eurasian Economic Union rules. The review covered product quality and manufacturing, nonclinical and clinical efficacy and safety data and pharmacovigilance and risk management plans.

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 approvals were based on the totality of clinical evidence for the combination in MSS mCRC, including mature results from the fully enrolled MSS mCRC cohort in the Phase 1b C-800-01 study and data from the randomised Phase 2 C-800-25 study. Findings from the clinical programme have been published in peer-reviewed journals, including Nature Medicine and Clinical Cancer Research, and presented at major oncology meetings.

Botensilimab is a multifunctional, Fc-enhanced anti-CTLA-4 antibody designed to activate innate and adaptive anti-tumour immune responses, including in tumours that have historically responded poorly to conventional immunotherapy. Balstilimab is a fully human anti-PD-1 antibody designed to block interactions between PD-1 and its ligands, PD-L1 and PD-L2, thereby supporting T-cell activity.

Following the Armenian approvals, Agenus plans to assess opportunities to seek marketing authorisations for the combination in the metastatic colorectal cancer setting in other Eurasian Economic Union member countries.

The combination is also available to eligible patients in France through the national Autorisation d’Accès Compassionnel programme, which provides reimbursed, hospital-based access for specified conditions. In other countries, access is available through physician-initiated named-patient programmes under local regulations.

The approved product information includes warnings about potential immune-mediated adverse reactions, including colitis and diarrhoea, hepatitis, pneumonitis, endocrinopathies, nephritis, myocarditis and pancreatitis, as well as infusion-related reactions. The medicines are authorised in Armenia only for the specified combination use in previously treated mCRC without active liver metastases; their use for other indications and in other countries remains investigational.