Expanded Access Program / Managed Access Program Overview

Expanded access/Managed access refers to regulatory mechanisms that provide compassionate drug access to patients with life-threatening or severely debilitating diseases when comparable or satisfactory alternative diagnostic and treatment options have failed or are unavailable.

We are committed to developing radiopharmaceuticals for diagnosis and treatments that positively impact patient health. We focus on research, education, and awareness while striving to bring innovative diagnostic imaging and treatment radiopharmaceutical agents to patients. As such, we conduct clinical trials for regulatory approvals. However, we recognize that some seriously ill patients may not qualify for our trials or lack access to satisfactory alternative diagnostic imaging and therapy options. In such cases, ITM may provide pre-approval access to an investigational drug under the Expanded Access Program/Managed Access Program (EAP/MAP) if specific conditions are met, including but not limited to:

• The patient has a serious or immediately life-threatening illness or condition, and no comparable or satisfactory alternative diagnostic or treatment options are available.
• The patient is ineligible for an ITM clinical trial or cannot be enrolled in a comparable external trial.
• The investigational drug (radiopharmaceutical) has sufficient clinical data to determine an appropriate dose for diagnostic imaging or treatment.
• A benefit-risk analysis supports the use of the investigational drug (radiopharmaceutical) as an imaging or treatment option.
• Access does not impact clinical trials or regulatory review.
• An adequate supply of investigational drug (radiopharmaceutical) as an imaging or treatment option is available, and providing it will not compromise supply for clinical trials.
• A regulatory mechanism exists in the country or region to support an expanded access/managed access program.

The following should be taken into account for EAPs/MAPs: Potential risks and benefits for the use of investigational drugs (radiopharmaceutical) are not yet established, and EAPs/MAPs are not intended for commercial use or hypothesis testing. We evaluate each request impartially on a case-by-case basis, considering the treating physician’s medical judgement, the patient’s clinical condition, the available clinical data, and the overall benefit-risk assessment, in full compliance with applicable regulatory requirements. Requests must be submitted by a treating physician, who must obtain necessary approvals and oversee patient monitoring and safety reporting.