Expanded Access - Metastatic Breast Cancer Trial Talk

Inside Clinical Trials

Expanded Access (EA) or “compassionate use” is an FDA-regulated pathway allowing a patient to receive an investigational drug outside of a clinical trial. This may be an option if you have already exhausted your treatment options, are not eligible for a trial, or cannot participate in a clinical trial.

Because the effectiveness (how well the drug works) and risks of using investigational drugs are unknown, the Expanded Access pathway requires a treating physician to apply on behalf of their patient. The full application process also involves the FDA, the IRB (Institutional Review Board), and the pharmaceutical company that makes the investigational drug.

 

Read below to learn about Expanded Access Programs (EAPs), single-patient expanded access, as well as how to apply.

FDA Publications

Pharmaceutical Company Information

How to Find Breast Cancer Expanded Access Drugs
  • The Expanded Access Navigator¬† The Reagan-Udall Foundation for the FDA provides free navigation information for finding breast cancer drugs available through the Expanded Access program.
How to Apply

Last Modified on March 14, 2021

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