Botensilimab, Balstilimab
Expanded access (EA) is designed to provide access to investigational therapy prior to registration by the applicable local regulatory agency. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient’s medical history and program eligibility criteria. EA will be available for indications where there is reasonable scientific basis for use, and availability will depend on territory eligibility. Agenus will review requests for EA to its investigational medicines according to the following criteria:
• The patient’s disease is serious or life-threatening.
• The patient has undergone appropriate standard treatments; there are no comparable or satisfactory alternative treatments for the disease or condition; the treatment is adjunct to an existing treatment option, and the treatment is not medically contra-indicated.
• Sufficient efficacy and safety evidence exists to make a benefit-risk analysis consistent with this policy and the potential patient benefit justifies any potential risks of treatment. (Such conditions are usually met at the end of Phase 1b studies, and depending on the clinical program, potentially even later.)
• Sufficient clinical data are available to identify an appropriate dose and treatment duration.
• The patient’s treating physician and qualified medical personnel at Agenus agree there is sufficient evidence to assume the potential benefit to the patient justifies potential risks.
• The patient is not eligible for participation in an ongoing clinical trial of the investigational medicine, including lack of access due to geographic limitations.
• EA will not adversely impact any clinical development program, in particular, the conduct of a pivotal clinical trial that is required for regulatory approval.
• The request must be made by the patient’s treating physician, who must be a qualified and licensed MD, unsolicited by Agenus or any other individual or organization working on behalf of Agenus.
If all these conditions are met, Agenus will consider EA requests from treating physicians.