Updated October 2026

At Agenus, we're committed to helping more patients facing cancer access potential new treatment options, particularly those with limited alternatives. We believe patients should have opportunities to access promising therapies as we work to advance their clinical development and pursue regulatory approvals around the world.

Our investigational immunotherapy combination, botensilimab (BOT), a multifunctional, Fc-enhanced anti-CTLA-4 antibody, and balstilimab (BAL), an anti-PD-1 antibody, together known as BOT+BAL, has shown encouraging results in clinical studies. 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.

Outside Armenia, BOT+BAL remains investigational and is not approved by the U.S. Food and Drug Administration (FDA). Agenus continues to support responsible patient access through clinical trials and authorized early-access programs where permitted under local regulations.

We encourage patients and their treating physicians to explore available options together, carefully considering individual medical circumstances, potential benefits and risks, and eligibility requirements. Our goal is to make information about these pathways clear and accessible to those seeking additional treatment options.

Below, you'll find information about available access pathways and how treating physicians can request additional guidance from Agenus.

1. Armenian Approval of Botvymo® (BOT) & Evamplix® (BAL)

In October 2026, the Ministry of Health of the Republic of Armenia granted the first marketing authorizations for Botvymo® (botensilimab) and Evamplix® (balstilimab), individually approved for use in combination.

Who may qualify?

Adults with microsatellite-stable (MSS) metastatic colorectal cancer without active liver metastases who have previously received available standard therapies, consistent with the approved Armenian product information.

The marketing authorizations apply within Armenia. Eligible patients residing outside Armenia may also seek treatment under the care of Armenian oncologists, subject to clinical evaluation and local requirements.

‍How can physicians learn more?

The marketing authorizations apply within Armenia. Eligible patients residing outside Armenia may also seek treatment under the care of Armenian oncologists, subject to clinical evaluation and local requirements.

Physicians seeking information about the Armenian approval and treatment access may contact Agenus Medical Affairs at:

med.info@agenusbio.com.

Read the Armenia Marketing Authorization Announcement

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2. France's Reimbursed Compassionate Access Pathway (Accès Compassionnel – AAC)

On behalf of eligible patients, we're pleased that France's health authority (ANSM) has authorized BOT+BAL for French patients through the AAC program—a positive step that validates its potential and provides fully reimbursed treatment in a hospital setting.

Adults with microsatellite-stable (MSS) metastatic colorectal cancer without active liver metastases who have previously received available standard therapies, consistent with the approved Armenian product information.

Treatment under AAC is governed by a national protocol that standardizes patient eligibility, treatment administration, data collection and follow-up under France’s ANSM. This means structured access with expert oversight and patient monitoring to ensure the best care is provided.

Who may qualify?

Adult French patients with:

• MSS metastatic colorectal cancer without active liver metastases, following progression on standard therapies and not eligible for clinical trials,
• Platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, after being treated with approved treatment options, and
• Advanced or metastatic soft-tissue sarcomas, including multiple high-grade histologies, following failure of standard therapies

European Union and European Economic Area (EU/EEA) residents may be able to access treatment via cross-border care, often with home insurance coverage (check insurance for prior approval).

‍Easy steps for doctors:

Start by emailing Agenus Medical Affairs to learn more at: AAC@AgenusBio.com.

Patient details are not needed in your first message—we'll guide you from there.

3. Global Paid Named Patient Program (Select Countries Outside the US)

Many countries across the globe have hospitals able to provide treatment with BOT+BAL and other Agenus medicines in development through certain pathways through a Named Patient Program, once certain patient eligibility criteria are met.

For patients living in a specific country that does not have the facilities to offer treatment in their home country, Cross Border Medical Care may be an option in certain countries that do offer Named Patient Programs. Some countries operate treatment‑abroad programs on a case‑by‑case basis.

There is a treatment charge associated with this program. Costs are determined based on local regulations and program policies. Patients should consult their national health authority and/or insurer to learn if coverage for a medicine in development either in or outside their home country is covered or decide if private pay is an option for you.

Physicians should reach out to learn more.

Who may qualify? Patients with serious conditions where BOT+BAL could help and where local country regulations enable this option.

Easy steps for doctors:

Email Agenus Medical Affairs at: NPP@AgenusBio.com . We'll make it simple.

4. Clinical Trials

Joining a clinical trial is an important way to access innovative treatments in development like BOT+BAL while helping advance science that could benefit everyone. Many patients find it rewarding and empowering!

‍Who may qualify? Every study has different enrollment criteria to join the study and requires informed consent.

Get started: explore ongoing trials. Your doctor can help check if a trial is appropriate for you.

5. Compassionate Access in Canada, Australia and New Zealand

Following the closure of the BATTMAN study, Agenus established a compassionate-access pathway to help support continued and new physician-led access to BOT and BAL for eligible patients with metastatic colorectal cancer in Canada, Australia and New Zealand.

This pathway is available both to patients who began receiving BOT and BAL through BATTMAN and to other eligible patients with metastatic colorectal cancer.

To be considered, patients must have exhausted available therapies for their disease, be intolerant of or ineligible for those therapies, and be medically eligible to receive BOT and BAL. Agenus will accept new requests through December 31, 2026. This is the deadline for submitting a new request and does not limit treatment duration.

Treating physicians should submit requests through their applicable regulatory pathway for their country.

In parallel with the applicable regulatory submission, physicians are encouraged to contact Agenus at compassionateuse@agenusbio.com to facilitate coordination of potential supply and required documentation.

Access in Other Countries

Physicians outside Canada, Australia and New Zealand who are seeking access to BOT and BAL should contact Agenus’ Named Patient Program. See details above.

6. Compassionate Use Program in the US (Expanded or Early Access)

Agenus recognizes the urgency faced by patients and families affected by serious cancers and remains committed to advancing immunotherapies that can ultimately reach as many patients as possible.

At this time, clinical trials are the primary pathway for patient access to botensilimab and balstilimab in the United States. Decisions regarding expanded or early access are made in alignment with regulatory requirements, clinical considerations, and the need to preserve the integrity of ongoing development programs.

Access pathways vary globally, and in certain countries outside the United States, investigational therapies may be available through Named Patient Programs or other early access mechanisms in accordance with local regulations. Agenus continues to prioritize clinical development and regulatory progress to support broader future access for patients.