What is expanded access?

Expanded Access (also known as Compassionate Use) is a potential pathway by which patients with serious or immediately life-threatening diseases or conditions may gain access to an investigational medicine outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

Expanded Access use is governed by US Food and Drug Administration (FDA) regulations under 21 C.F.R. Part 312, Subpart I, and is intended solely for treatment purposes and not for the generation of clinical data.

FDA considerations for Expanded Access eligibility

The FDA generally considers whether all of the following criteria are met when evaluating Expanded Access requests:

1. The patient has a serious or immediately life-threatening disease or condition.
2. There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
3. Patient enrollment in a clinical trial is not possible.
4. The potential patient benefits justifies the potential risks of treatment.
5. Providing the investigational medicine product will not interfere with ongoing investigational trials that could support the development or marketing approval for the treatment indication.

AVEO Expanded Access policy

AVEO is committed to advancing investigational medicines through well-controlled clinical trials and regulatory pathways designed to establish safety and efficacy.

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 the 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 will be evaluated and responded to on a case-by-case basis and must come from a patient’s treating physician and be sent to: ExpandedAccess@AVEOOncology.com. The request should include the rationale for expanded access, a list of available therapeutic options, and why the AVEO investigational medicinal product is preferred.

Receipt of the request will be confirmed electronically within 3 business days. Following receipt of the request, AVEO may request additional information as needed to complete our assessment. Once all of the required information is provided to AVEO for review by our internal medical team, a decision on access will be made within 5 business days.

For information about clinical trials conducted by AVEO or supported by one of our development partners, please visit https://clinicaltrials.gov.

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.