Project

BOT+BAL is Investigational and May be Accessed Through Clinical Trials and Authorized Pathways

Agenus

DOI: 10.26303/x2yk-8n81

Key takeaways

  • BOT+BAL is approved in Armenia for eligible patients with previously treated MSS metastatic colorectal cancer and remains investigational elsewhere.
  • Clinical trials remain the preferred access pathway for investigational BOT+BAL.
  • Outside clinical trials, access may be possible through France’s reimbursed AAC program or physician-initiated pathways in certain other countries.
  • Eligibility and availability are determined case by case under applicable regulatory requirements; treating physicians should contact Agenus Medical Affairs for guidance.
  • Agenus has support in place to help clinicians understand different access pathway; clinicians should use the company’s current resources and dedicated contact channels to understand more.

What is it about?

Agenus is committed to expanding patient access to BOT+BAL through regulatory approvals, clinical trials and authorized early-access pathways. Following the first marketing authorizations for Botvymo® (botensilimab) and Evamplix® (balstilimab) in Armenia for eligible patients with previously treated MSS metastatic colorectal cancer, access is also available through select early-access programs where permitted by local regulations. BOT+BAL remains investigational outside Armenia and is not approved by the U.S. Food and Drug Administration (FDA).

For eligible patients who cannot participate in a clinical trial and have exhausted available treatment options, BOT+BAL may be accessible through physician-initiated, regulatory-authorized pathways in certain countries:

In France, the national Autorisation d’Accès Compassionnel (AAC) provides hospital-based, reimbursed access governed by a standardized, national protocol. Adult patients with the following conditions may be eligible: MSS metastatic colorectal cancer without active liver metastases; treatment-refractory or -resistant ovarian, fallopian-tube or primary peritoneal cancers; advanced or metastatic soft-tissue sarcomas. EU/EEA patients may also be able to use cross-border care, subject to local approval and insurance arrangements.

Paid named-patient programs: In select countries outside the United States, treating physicians may request BOT+BAL for individual patients where permitted by local regulations. Eligibility, treatment location, regulatory requirements and payment or insurance coverage vary by country. Cross-border care may be possible in certain circumstances.

United States: Clinical trials are currently the primary pathway for access to BOT+BAL. Decisions regarding any expanded- or early-access requests are governed by regulatory requirements, clinical considerations and the need to preserve ongoing clinical development.

Outside approved use in Armenia, access requests must be initiated and medically managed by a treating physician. Availability is not guaranteed and depends on individual eligibility, local regulations, institutional participation and product supply.

Why is it important?

Patients who have exhausted available therapies may have limited treatment options and may not be able to participate in a clinical trial. Authorized access pathways provide a structured mechanism through which treating physicians can request investigational BOT+BAL for appropriate patients where local regulations permit.

These programs do not replace controlled clinical trials or regulatory review. They complement clinical development by supporting responsible access, safety monitoring and structured collection of real-world experience while BOT+BAL continues to be evaluated.

To explore more about BOT+BAL, including recent and planned research, click below on Agenus BOT+BAL Immunotherapy Research Showcase.

Page published: 12-Nov-2026

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Who is involved?

Important information

In October 2026, BOT+BAL reached an important milestone with its first marketing authorizations in Armenia, where Botvymo® (botensilimab) and Evamplix® (balstilimab) were approved for use in combination in eligible adults with microsatellite-stable (MSS) metastatic colorectal cancer without active liver metastases who have previously received available standard therapies.

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