LEXINGTON, Mass. — October 8, 2026
Agenus Inc. announced that Armenia’s Ministry of Health has granted the first-ever marketing authorizations for Botvymo® (botensilimab) and Evamplix® (balstilimab), approved separately for use in combination to treat adults with previously treated microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases. The authorizations became effective on October 2, 2026, following regulatory review of product quality, manufacturing, nonclinical and clinical evidence, and pharmacovigilance information. The approvals are conditional, valid for one year, and renewable based on annual clinical updates provided to the Armenian regulator.
Dual Immunotherapy Targets Antitumor Immune Responses
Botensilimab is an Fc-enhanced anti-CTLA-4 antibody designed to stimulate innate and adaptive antitumor immune responses, including in tumors that have historically shown limited responses to conventional immunotherapy. Balstilimab is an anti-PD-1 antibody intended to sustain antitumor T-cell activity. Under the approved product information, Botvymo is administered intravenously at 75 mg every six weeks for up to four doses, while Evamplix is administered intravenously at 240 mg every two weeks for up to two years or until disease progression or unacceptable toxicity.
Clinical Evidence Supports Regulatory Decisions
The Armenian authorizations were supported by the totality of clinical evidence from Agenus’ Phase 1b C-800-01 study and randomized Phase 2 C-800-25 study in MSS metastatic colorectal cancer. The company cited two-year survival findings from the Phase 1b program and results from the Phase 2 study in patients without active liver metastases. Clinical findings have been published in peer-reviewed journals and presented at major oncology meetings. The approved indications apply to previously treated adults who meet the specified criteria; the reported evidence does not establish that the combination benefits every patient with metastatic colorectal cancer.
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Agenus Evaluates Broader Regional Access
Agenus plans to evaluate potential marketing authorization applications in other Eurasian Economic Union member countries. The Armenian approvals apply only within Armenia. The company also reports access pathways in France through the national Autorisation d’Accès Compassionnel program for eligible patients and named-patient programs in certain other countries, subject to local regulations. The approved product information includes warnings for immune-mediated adverse reactions affecting organs such as the colon, liver, lungs, endocrine system, kidneys, heart and pancreas, as well as infusion-related reactions. Healthcare professionals are advised to consult the local approved prescribing information before use.
Source::Agenus press release
