Expanded Access Policy
Single-Patient Expanded Access Policies and Criteria
Repare Therapeutics is a leading clinical-stage precision oncology company enabled by our proprietary synthetic lethality approach to discovering and developing novel therapeutics. Repare conducts clinical trials in individuals to evaluate investigational medicines in order to obtain information on safety and efficacy that may be used to support marketing approval and subsequent wider accessibility of the product to patients. Investigational medicines are drugs that have not been approved by regulatory authorities.
Repare seeks to retain the ability to manufacture and supply investigational medicines in a fair and equitable manner and in a volume that assures adequate supply for ongoing clinical trials and development programs. Hence, at this time, Repare is unable to provide its investigational medicines on an expanded access or right to try basis. For patients seeking access to our investigational medicines before they are approved by a regulatory authority, participation in one of Repare’s clinical trials is the most appropriate way to access these investigational medicines. To learn more about available clinical trials by Repare, please visit www.reparerx.com, or visit https://clinicaltrials.gov and search by company, disease or medicine.
If you have additional questions, please speak with your physician or contact Repare at [email protected].
Consistent with the 21st Century Cures Act, Repare may revise this policy at any time.