Agenus Inc. announced that France's National Agency for Medicines and Health Products Safety (ANSM) has approved an updated national treatment protocol for the investigational immunotherapy combination of botensilimab and balstilimab under the Autorisation d'Accès Compassionnel $(AAC)$ framework. The revised protocol expands fully reimbursed, hospital-based compassionate access to include eligible patients with advanced or metastatic ovarian cancer and soft-tissue sarcomas, in addition to previously authorized access for patients with microsatellite-stable metastatic colorectal cancer without active liver metastases. This update broadens patient eligibility and standardizes treatment and monitoring procedures across participating French hospitals. Botensilimab and balstilimab remain investigational and are not approved for commercial marketing.

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