Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

“Expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. While this use involves an investigational product, this is not a research study.”

Q5. Do compassionate use/expanded access requests for previously approved or new applications need to submit the petition to resume in-person interactions/new enrollment? No. Since compassionate use/expanded access requests are designed to entail only treatment and not considered research, you do not have to submit the petition to initiate in-person activity or new research. To avoid confusion we recommend you include the following sentence in Section 1 (General Information), Item 6 when submitting new single patient/compassionate use requests. “This is a new [single/multiple] patient expanded access treatment request.”

Conditions: Prostate Cancer