Expanded access, also known as compassionate use, is a potential pathway for a patient with an immediately life-threatening condition or serious disease to gain access to an investigational drug or other medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
According to the FDA’s published guidelines, expanded access may be appropriate when all the following apply:
- Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
Poseida is committed to developing safe and effective therapies for patients, and strive to put patients first. Our goal is to provide best-in-class CAR-T therapies to patients as soon as possible through efficient drug development. For more information, please contact us at email@example.com.