Expanded Access Policy

It is our duty to carefully evaluate the safety and efficacy of any potential new medicines for a particular disease area. We believe clinical trials are the best and most appropriate way to do that. When successful, data from these studies form the basis of regulatory (i.e. FDA, EMA, or similar regulatory agencies) approvals, which ensure sustained access to the medications patients need.

We also recognize that patients and physicians may seek access to investigational medicines outside of clinical trials. While participating in clinical studies remains the primary and most appropriate pathway for accessing investigational therapies, Geron may consider requests for expanded access (also known as early access, compassionate use, or named patient program) in certain circumstances, guided by patient availability for that medicine in their country, patient need, scientific evidence, available drug supply, and applicable regulations.

Geron continues to assess the eligibility requirements and criteria for Expanded Access to imetelstat. At this time, a United States Expanded Access Program (EAP) or Compassionate Use Program is not available for any disease area. To inquire about programs outside of the United States, please email [email protected] and we will acknowledge receipt of your request within 3 business days. We will re-evaluate this policy from time to time.