Expanded Access Policy
Expanded access (EA) or compassionate use, is used to describe treatment with an investigational product for a patient with a serious or immediately life-threatening illness when there are no comparable or satisfactory alternative treatments available, and the patient is ineligible or unable to participate in a clinical trial. The US Food and Drug Administration (FDA) has set forth guidelines when considering expanded access. They include:
- The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or enrolling in a clinical trial).
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information.
- Whether granting expanded access would interfere with clinical trials that could support a product’s development or approval.
At this time, Instil Bio does not provide access to our investigational products through EA or Right to Try requests. We plan to review this policy from time to time and will post updates accordingly. This EA Policy is being posted pursuant to Section 3032 of the 21st Century Cures Act and section 561 of the United States Food, Drug, and Cosmetics Act, as amended.
If you are a patient who is interested in accessing our investigational cell therapies, please speak with your physician. You may also learn more about ongoing clinical trials by going to www.clinicaltrials.gov and searching for Instil Bio.
If you are a physician who is interested in learning more about our investigational cell therapies, or participating in our clinical trials, please submit an inquiry to [email protected].