Jennifer Buell, President and Chief Executive Officer at MiNK Therapeutics, shared a post by MiNK Therapeutics, on LinkedIn:
“France Grants Reimbursed Compassionate Access (AAC) for Agenus’ BOT/BAL in Refractory MSS Metastatic Colorectal Cancer.
As a board member of Agenus, I am proud that our investigational combination of botensilimab plus balstilimab (BOT/BAL) is now available to eligible patients with refractory microsatellite-stable colorectal cancer under France’s compassionate access (Accès compassionnel, or AAC) framework.
This is more than a milestone for Agenus—it is a lifeline for patients and families facing one of the hardest-to-treat cancers. Published clinical data with BOT/BAL show durable responses and long term survival in this population, in fact, more than 42% of patients are alive beyond a median of 2 year follow-up. Through AAC, patients in France can now access therapy with 100% reimbursement, while hospitals and physicians receive clear guidance and support.
By contrast, in the U.S., compassionate use depends on single-patient INDs (SPINDs). These require FDA approval, institutional review board sign-off, and sponsor support on a case-by-case basis. The barrier is even higher because—unlike France—U.S. law prohibits reimbursement for investigational products prior to commercial approval. Medicare, Medicaid, and private insurers cannot pay for a therapy that has not received FDA approval, even if no alternatives exist.
The intent is to protect patients and payers from unproven interventions, but in practice it means the cost falls to hospitals and/or companies. Many institutions, facing regulatory and financial strain, are now declining to support SPINDs altogether.
The result? U.S. patients often wait longer, face more obstacles, and sometimes miss out entirely on access to promising investigational therapies—while patients in France and elsewhere can receive care under nationally funded programs.
France’s AAC shows what’s possible when policy meets innovation. The U.S. (U.S. Department of Health and Human Services (HHS and FDA) must seek a better balance—one that ensures safety and evidence generation without closing the door on hope for patients with no other options.”
More posts featuring Jennifer Buell on OncoDaily.