We are dedicated to safely providing new treatment options to patients in need.
Expanded access refers to a situation where a patient with a serious condition who has exhausted all available treatment options, and an ongoing clinical trial is not an option, receives approval to use an investigational drug outside of a clinical trial.
We welcome requests for expanded access from physicians treating patients with the diseases that our investigational drugs are intended to treat, and we take great care to have each individual patient case assessed by a physician on our staff. However, it is important to remember that investigational drugs have not yet received regulatory approval and that their potential risks and benefits are therefore not yet established. Doctors and patients should consider all possible benefits and risks when seeking expanded access to an unapproved investigational drug.
We consider a number of factors consistent with the FDA and other regulatory agencies’ guidelines when considering whether to grant expanded access with respect to our investigational drugs. These factors include:
- The illness must be serious of life-threatening with no viable treatment options such as approved products or active clinical trials.
- There must be sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on currently available safety and efficacy information for the investigational drug.
- We must have the ability to provide the investigational drug in a fair and equitable manner so that there is adequate manufacturing capacity for our ongoing clinical trials and other existing patients.
- Granting expanded access may not in any way compromise the scientific validity of Five Prime’s broader development programs or interfere with or delay current clinical trials or regulatory filing, which are designed to make the investigational drug available to many more patients.
Decisions about granting expanded access to our investigational products are made after considerable thought. Our first concern is the safety and well-being of patients. At this time, we believe that participation in one of our clinical trials is the most appropriate way to access our investigational drugs. If you have questions or would like more information about enrolling in one of our clinical trials, please contact us at email@example.com. We anticipate acknowledging receipt of requests sent to this email within five business days.
In line with the 21st Century Cures Act, we may revise this policy at any time without notice. To the extent we allow expanded access to any of our investigational drugs, 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.