On October 8, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported that the Ministry of Health of the Republic of Armenia has granted marketing authorizations for Botvymo (botensilimab, BOT) and Evamplix (balstilimab, BAL), each approved for use in combination with the other for the treatment of adult patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases who have previously received available standard therapies. These are the first marketing authorizations for either medicine anywhere in the world. The approvals are expected to benefit patients in Armenia as well as patients who travel to Armenia for treatment under the care of Armenian oncologists.
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Botensilimab is a multifunctional, Fc-enhanced anti-CTLA-4 antibody designed to activate innate and adaptive antitumor immune responses, including in tumors that have historically responded poorly to conventional immunotherapy. Balstilimab is an anti-PD-1 antibody designed to sustain antitumor T-cell activity.
The approvals are effective as of October 2, 2026. They follow a rigorous review by Armenia’s regulatory authorities of the complete registration dossier, submitted in the international Common Technical Document format used under Eurasian Economic Union rules. The review covered product quality and manufacturing (chemistry, manufacturing and controls), nonclinical data, clinical efficacy and safety data, and the pharmacovigilance system and risk management plan. BOT and BAL were separately submitted and approved for use as a combination regimen. Under the approved product information, Botvymo is administered at 75 mg intravenously every 6 weeks for up to 4 doses, in combination with Evamplix at 240 mg intravenously every 2 weeks for up to 2 years or until disease progression or unacceptable toxicity.
Each marketing authorization is conditional and valid for one year and is renewable based on the clinical updates that Agenus will provide to the Armenian regulator each year.
"Armenia is the first country in the world to grant marketing approval for BOT+BAL," said Garo H. Armen, PhD, 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."
Clinical Evidence Supporting the Approvals
The Armenian approvals were based on the totality of clinical evidence for BOT+BAL in MSS mCRC, including mature results from the fully enrolled MSS mCRC patient cohort from the Phase 1b C-800-01 study and data from the randomized Phase 2 C-800-25 study. Results from this clinical program have been published in peer-reviewed journals, including Nature Medicine and Clinical Cancer Research, and presented at major oncology congresses, including the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium. The efficacy and safety data supporting the approvals are summarized in the approved product information for Botvymo and Evamplix.
Regional Opportunities
Following the Armenian approvals, Agenus will evaluate the potential to seek marketing authorizations for BOT+BAL in the MSS metastatic colorectal cancer setting in other Eurasian Economic Union member countries.
Access to BOT+BAL Outside Armenia
The Armenian marketing authorizations apply within the territory of Armenia.
In France, the national Autorisation d’Accès Compassionnel (AAC) program provides fully reimbursed, hospital-based access to BOT+BAL for eligible patients with MSS metastatic colorectal cancer without active liver metastases, platinum-resistant or platinum-refractory ovarian cancer, and certain advanced soft-tissue sarcomas. In a growing number of other countries, BOT+BAL is available through physician-initiated named-patient programs under local regulations. BAP Pharma serves as Agenus’ global partner for the French AAC pathway and named-patient access programs.
Physicians seeking information about authorized access pathways can visit the Patient Access section of our corporate website.
Important Safety Information
The approved product information for Botvymo and Evamplix includes warnings and precautions for immune-mediated adverse reactions, including colitis and diarrhea, hepatitis, pneumonitis, endocrinopathies, nephritis, myocarditis and pancreatitis, as well as infusion-related reactions. Healthcare professionals in Armenia should consult the approved product information before prescribing.
(Press release, Agenus, OCT 8, 2026, View Source [SID1234673287])