Expanded Access Program / Managed Access Program Overview

Expanded access/Managed access refers to regulatory mechanisms providing compassionate drug access for patients with life-threatening or severely debilitating diseases when commercial therapies have failed or are unavailable.

We are committed to developing radiopharmaceutical treatments that positively impact patient health. We focus on research, education, and awareness while striving to bring innovative treatments 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 have alternative 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:

• The patient has a serious or life-threatening illness and no remaining treatment options.
• The patient is ineligible for an ITM clinical trial.
• The investigational drug has sufficient clinical data to determine an appropriate dose.
• A benefit-risk analysis supports treatment.
• Access does not impact clinical trials or regulatory review.
• Adequate drug supply is available.

EAPs/MAPs are not intended for commercial use or hypothesis testing. We evaluate requests case by case, ensuring fairness and regulatory compliance. Requests must be submitted by a treating physician, who must obtain necessary approvals and oversee patient monitoring and safety reporting.