France Expands National AAC Access for Agenus' Botensilimab + Balstilimab for Ovarian Cancer and Soft-Tissue Sarcomas>

(BUSINESS WIRE) -- Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that France’s National Agency for Medicines and Health Products Safety (ANSM) has approved an updated national treatment protocol for botensilimab (BOT) plus balstilimab (BAL) under France’s Autorisation d’Accès Compassionnel (AAC) framework. The updated protocol expands France’s previously granted AAC authorization for BOT+BAL in patients with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases to eligible patients with certain ovarian cancers and soft-tissue sarcomas—diseases with substantial unmet medical need after standard options have been exhausted. The revised protocol is designed to broaden the eligibility criteria, allowing more patients with advanced solid tumors to have early access to BOT+BAL under reimbursed compassionate use, and to enhance monitoring and treatment procedures in participating hospitals. BOT+BAL is a chemotherapy- and radiation-free immunotherapy combination being evaluated in clinical studies and available in compassionate access settings authorized by ANS...(BUSINESS WIRE) -- Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that France’s National Agency for Medicines and Health Products Safety (ANSM) has approved an updated national treatment protocol for botensilimab (BOT) plus balstilimab (BAL) under France’s Autorisation d’Accès Compassionnel (AAC) framework. The updated protocol expands France’s previously granted AAC authorization for BOT+BAL in patients with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases to eligible patients with certain ovarian cancers and soft-tissue sarcomas—diseases with substantial unmet medical need after standard options have been exhausted. The revised protocol is designed to broaden the eligibility criteria, allowing more patients with advanced solid tumors to have early access to BOT+BAL under reimbursed compassionate use, and to enhance monitoring and treatment procedures in participating hospitals. BOT+BAL is a chemotherapy- and radiation-free immunotherapy combination being evaluated in clinical studies and available in compassionate access settings authorized by ANS...{}