Updated September 2025
Agenus is committed to making our investigational medicines available to patients with cancer. Our goal is to provide access to our investigational medicines at the appropriate time and in the correct manner for patients. You can find information below on the available access programs and our Access to Investigational Medicines Policy here.
It is important to remember that investigational medicines have not yet received regulatory approval; therefore, potential risks and benefits are not formally established. Healthcare professionals and patients should consider all possible benefits and risks when seeking access to an investigational medicine.
Agenus believes that participating in clinical trials is the best way and preferred route for patients to access Agenus investigational medicines prior to approval. To participate in a trial, you must meet certain criteria. For those who meet the criteria to join a clinical trial, participation also offers the chance to contribute to medical research that may benefit many others. Participation in a clinical trial may include risks; that is why “informed consent” is a required step in the process of enrolling.
If you meet the criteria to join a trial, this may be the most appropriate way to access our investigational therapies.
For information on enrolling clinical trials, click here.
In select countries outside the United States, patients with serious or life-threatening conditions may be able to access our investigational therapies through a Paid Named Patient Program (NPP). Many countries across the globe have hospitals able to provide treatment with Agenus investigational medicines, once the patient eligibility criteria are met.
For patients living in a specific country that does not have the facilities to provide care, Cross Border Medical Care may be an option. Some countries operate treatment‑abroad programs on a case‑by‑case basis. Patients should consult their national health authority and or insurer to learn if coverage for an investigational treatment in outside their home country is an option.
The Global Paid Named Patient Program and cross border medical care requires patients to be under the care of a licensed physician who believes our investigational therapy may be appropriate.
Access to treatment through this program must be requested by the patient’s treating physician, who will be responsible for managing care.
Please note: there is a treatment charge associated with this program. Costs are determined in accordance with local regulations and program policies. Patients should consult their national health authority and/or insurer for potential coverage details.
Our Paid Named Patient Program is managed by Tanner Pharma. Physicians interested in learning more or requesting access can either contact Tanner directly or by submitting a request to Agenus Medical Information at:
Contact Tanner Pharma at: Bot.bal@tannerpharma.com
Contact Agenus Medical Information at: Med.info@agenusbio.com
In France, certain patients with advanced microsatellite-stable metastatic colorectal cancer (MSS mCRC) may be able to access the investigational combination of botensilimab and balstilimab (BOT/BAL) through a French Compassionate Access Program, known locally as Accès Compassionnel (AAC).
This program is authorized by France’s National Agency for Medicines and Health Products Safety (ANSM) and is intended for patients who:
Use of BOT/BAL in the hospital setting is fully reimbursed by France’s national health system (Assurance Maladie) for French residents covered by public health insurance. A temporary company-set price, known as “indemnity charge” is invoiced to the hospital, in accordance with French AAC reimbursement rules.
All requests for AAC access must be initiated by the treating physician, who will oversee treatment and reporting requirements. BOT and BAL are investigational and are not authorized for commercial sale in France.
Patients in European Union and/or European Economic Area (EU/EEA) countries may benefit from cross-border care rights which may be reimbursed by their home country insurers. Prior authorization is often required for hospital and/or specialist care. Consult your National Contact Point and/or insurer before traveling to an EU/EEA country for care.
Treatment through the Compassionate Access Program in France is managed by our partner, MyTommorrows. Physicians interested in learning more or requesting access can either contact MyTomorrows directly or by submitting a request to Agenus Medical Information at:
Contact MyTomorrows at: Agenus_eap@myTomorrows.com
Contact Agenus Medical Information at: Med.info@agenusbio.com
In rare cases, patients who are not eligible for a clinical trial and who have no other treatment options may access one of our investigational therapies outside of a trial. This is known as Compassionate Use or sometimes referred to as Expanded Access or Early Access.
This type of access is only granted when specific criteria are met, and the request must be initiated by the patient’s treating physician. Each request is evaluated carefully in accordance with our policy and applicable regulations. To learn more about our approach and eligibility criteria, please refer to our Access to Investigational Medicines Policy here.
Treating physicians can submit a request for compassionate use by sending an email to Agenus Medical Information. Please do not include any identifying patient information in the initial email.
Contact Agenus Medical Information at: med.info@agenusbio.com
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