What is expanded access?

When enrollment into a clinical trial is not an option and where all currently available treatment options have been exhausted, an investigational medicine may be provided prior to regulatory approval or commercial availability under a provision referred to as Expanded Access (also known as Compassionate Use) by the US Food and Drug Administration (FDA).

Expanded Access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational drug for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy exists.

FDA considerations for Expanded Access eligibility

1. A patient must have a serious disease or condition, or their life is immediately threatened by their disease or condition.
2. No comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition exists.
3. Patient enrollment in a clinical trial is not possible.
4. Potential patient benefits justify the potential risks of treatment.
5. Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

AVEO Expanded Access policy

As a general policy, AVEO will not provide investigational medicines to patients until a dose and schedule has been established for the agent, preliminary data exists that that agent has some evidence of activity in a particular indication, and the investigational medicine is found to be safe as a result of a risk-benefit evaluation.

AVEO may reconsider making one or more of its investigational medicines available through an Expanded Access Program in the future. All requests for Expanded Access must come from a patient’s treating physician and will be evaluated and responded to on a case-by-case basis. A patient’s treating physician can expect acknowledgement of receipt of their request within 5 business days.

As authorized by the 21st Century Cures Act, AVEO may revise this Expanded Access Policy at any time. The posting of this policy by AVEO shall not serve as a guarantee of access to any specific investigational medicine by any individual patient.

If you have additional questions, please speak with your treating physician or contact AVEO at ExpandedAccess@AVEOOncology.com.