RegulatoryCompany release

Armenia grants world-first approvals for Agenus's botensilimab and balstilimab in colorectal cancer

🇺🇸 Agenus Inc (AGEN) · Thu 05 Nov 2026

Armenia's Ministry of Health has authorised Botvymo and Evamplix for previously treated MSS metastatic colorectal cancer, as Agenus reports Q3 2026 results and readies its Phase 3 ROBBIN trial.

Agenus said Armenia's Ministry of Health has granted the first marketing authorisations anywhere in the world for botensilimab (Botvymo) and balstilimab (Evamplix). The company announced the approvals alongside its third-quarter 2026 results on 5 November 2026.

The two products are authorised for use together in adults with microsatellite-stable (MSS) metastatic colorectal cancer who have been previously treated and who do not have active liver metastases.

Agenus also reported that its Phase 3 ROBBIN trial, in high-risk Stage II/III MSS colon cancer, is on track to dose its first patient in the first quarter of 2027. The company said the trial is supported by peer-reviewed Phase 2 data from the NEST and UNICORN studies, which showed pathologic complete responses of roughly 30%.

The source material available did not include further detail on the Armenian approval, such as the regulatory pathway, conditions attached to the authorisation or launch timing, so those points remain unconfirmed.

What it means for your team

  • The Armenian authorisations are reported as first-in-world approvals for both products; teams tracking the combination should note that no approval in the US or EU has been reported in this item.
  • Details of the Armenian conditions, post-authorisation obligations and any safety-reporting requirements were not disclosed, so pharmacovigilance teams should await further documentation.
  • ROBBIN's planned first-patient dosing in Q1 2027 signals a move towards an earlier-stage, higher-risk colon cancer setting, relevant for those monitoring clinical development and future market-access planning.

Company's press release (SEC filing): Agenus Inc ↗

Article written by VigiEye from the official source (Agenus Inc). Claims are the company's own. AI-assisted; check the source before acting.

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