Patients

Expanded access, also called compassionate use, refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent or treat a serious or immediately life-threatening condition in a patient. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected. We understand the need for expanded access programs, and we recognize the importance of having an appropriate policy.

Several factors, consistent with the US Food and Drug Administration (US FDA) and other regulatory agencies’ guidelines should be taken into account 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 open clinical trials)
• There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy information
• The ability to provide a therapy in a fair and equitable manner, so that there is adequate manufacturing capacity to provide therapies across all ongoing clinical trials and expanded access programs
• Whether granting expanded access would potentially compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients

Given the early state of our development programs, we believe that participation in one of our clinical trials is the most appropriate way to access our investigational therapies. Therefore, we are not currently making our investigational products available through an expanded access program. If you have additional questions, please speak with your physician or contact clinicaltrials@relaytx.com.

In line with the 21st Century Cures Act, Relay Therapeutics may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.