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News
Armenia has become the first country to approve the immunotherapy combination of botensilimab and balstilimab for adults with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases. This is a significant milestone, as MSS mCRC has historically been resistant to immunotherapy. The conditional approvals are valid for one year and supported by clinical trial data showing a 21% response rate and a median overall survival of over 21 months.
Armenia's Ministry of Health has made history by granting the world's first marketing authorizations for botensilimab (Botvymo) and balstilimab (Evamplix) — a dual immunotherapy combination — for adults with previously treated MSS metastatic colorectal cancer (mCRC) without active liver metastases. MSS mCRC is notoriously resistant to immunotherapy, making this a landmark moment in oncology. The conditional approvals are valid for one year and renewable based on annual clinical updates.
The approvals were backed by data from the phase 1b C-800-01 trial, which enrolled 123 patients without active liver metastases. The combination showed meaningful and durable responses in a population with very limited options, including those who had received prior anti-PD-(L)1 therapy.
By the Numbers:
Why it matters: MSS mCRC accounts for the vast majority of metastatic colorectal cancer cases and has long been considered an immunotherapy "cold" tumor. This first-ever approval signals a potential turning point, offering a new treatment avenue for patients who have exhausted standard therapies.
