The short answer
Expanded access, or compassionate use, is a way for a person with a serious illness to try an unapproved treatment outside a clinical trial when no other options remain and they cannot join a trial.
Expanded access lets some patients use an unapproved treatment outside a trial.
It is also called compassionate use.
It is meant for serious conditions with no good alternatives.
It usually requires that the person cannot join a suitable trial.
Choose how you want to read this
The whole article, with every detail and caution.
A path outside a trial
Expanded access is often called compassionate use. It is a way for a person with a serious illness to try a treatment that is not yet approved, without joining a clinical trial. It exists for situations where the usual options have run out.
Who it is for
Expanded access is generally meant for people with a serious or life-threatening condition. It applies when someone cannot take part in a suitable clinical trial, and when no satisfactory approved treatment is left to try. It is not a substitute for a trial when one is available.
Who must agree
Several parties have to line up. Your own licensed doctor must submit the request. The company that makes the investigational treatment must agree to supply it. No law or policy requires a company to do so. A company may say no, or may not have enough of the drug to go around. The FDA must authorize the use, and it says the vast majority of requests it receives may proceed. An institutional review board, the ethics panel that watches over research, also has to approve. You then go through informed consent about the possible risks and benefits before treatment starts, and you can stop at any time.
How it differs from a trial
A clinical trial is a study. It is designed to answer research questions under a controlled plan. Expanded access is about giving a treatment to a patient who needs it. Collecting research data is not the main point. If you think it might apply to you, your oncologist is the person to start the conversation with.
Project Facilitate, for cancer specifically
Oncology has its own help desk. The FDA Oncology Center of Excellence runs Project Facilitate. It is described as a single point of contact call and information center.
Its purpose is to help oncology healthcare providers and regulatory professionals through the process of submitting an expanded access request for an individual patient. The FDA is honest that the application process can be complex, and this is the group that walks a provider through it.
What it cannot promise
It cannot promise the treatment works. The FDA says it directly. Investigational products may, or may not, be effective, and they may cause unexpected serious side effects.
Cost can fall on you. A company may charge, but only to recover its costs. The FDA says private insurance and Medicare usually do not cover investigational products. Ask your team about cost early.
It does not come with a timeline you can count on. Emergency requests move faster than routine ones, but no one can promise a date. For emergencies, the FDA says a physician can phone the review division, and treatment may begin right after FDA emergency authorization.
Sources
Common questions
What is expanded access?
Expanded access, sometimes called compassionate use, is a pathway that allows a person with a serious illness to receive an investigational treatment outside a clinical trial when they have no comparable options.
Who qualifies?
It is generally for people with a serious or life-threatening condition who cannot take part in a clinical trial and have no satisfactory approved treatment available.
Who has to agree?
The treating doctor must request it, the company that makes the treatment must agree to provide it, and the FDA must authorize it.
Is it the same as a clinical trial?
No. A trial is a study designed to answer research questions. Expanded access is about providing treatment to a patient, not primarily about gathering research data.
Does FDA approval of my request mean I will get the drug?
No. The company that makes the investigational product decides whether to provide it. The FDA reviewing a request is a separate step from a company agreeing to supply the drug.
What is Project Facilitate?
It is a call and information center run by the FDA Oncology Center of Excellence that helps oncology healthcare providers and regulatory professionals submit expanded access requests for individual patients.
Will the drug work?
There is no promise. The FDA states plainly that investigational products have not been approved or cleared and may, or may not, be effective, and may cause unexpected serious side effects.
Questions to ask your doctor
Being prepared helps you get the most out of your appointments. Save or print these questions.
Tap a question to save it to your list (kept on this device).
Talk with a trained specialist or navigator
Cancer Explained provides educational guidance, but does not replace trained specialists, social workers, or your medical team.
Talk to a trained cancer information specialist
Free, confidential assistance from NCI Cancer Information Service via phone, chat, or email.
Contact your oncology team
Locate after-hours contact numbers, portal messages, or urgent triage phone lines.
Find a patient navigator
Get one-on-one help with appointments, logistics, translation, and care coordination.
Find a genetic counselor
Discuss inherited mutation risk, family history, and genetic testing options.
Find an oncology social worker
Access emotional counseling, family support groups, and mental health resources.
Find a financial navigator
Locate copay assistance foundations, grant programs, and lodging/travel support.
Find a clinical-trial specialist
Search matching studies and speak with NCI trial information specialists.
Get urgent help
Fever of 100.4°F (38°C) or higher during chemo, severe pain, or trouble breathing: call your cancer care team right away, day or night. Call 911 for an emergency.
Plain-language explanation of the published sources cited on this page. AI-assisted, source-checked, not clinician-reviewed.
Written by: Cancer ExplainedSources last checked: 2026-07-14 what this meansLast updated: 2026-10-16Next planned review: 2027-01-14
Review details and limits
Cancer Explained does not originate medical claims. Every page restates guidance already published by the National Cancer Institute, the CDC, the USPSTF and the FDA, in plain language, with the source cited so you can check the original yourself. AI does the translating and organizing; automated checks test claims, citations, clarity and safety before anything publishes, and this is translation and navigation, not clinical judgment. Nothing here is personal medical advice, and no page can account for your particular situation.
Editorial status — Source checked. This page was written with AI assistance and then compared with the sources listed on it, looking for statements those sources do not back up. That check is not a sentence-by-sentence record and can miss errors. It is not a medical review, and it does not confirm the page is complete or right for your situation.
General education — varies by person. Answers genuinely differ between people. This page explains what commonly varies and points you to your care team for your situation.
Human medical review: not completed. Pages here are not signed off by a clinician before they publish. That is not an oversight we are quietly working around: we restate published guidance and cite it, so the authority belongs to the source rather than to us, and every page names where its claims come from — you can verify us instead of trusting us. Where a volunteer clinician has reviewed a page, their name and credentials appear on it; where no name appears, no clinician has checked it. We are glad to have reviewers and are recruiting them, and we do not hold pages back waiting for one. Use this site to understand your situation and to ask better questions of the people treating you.
Words to know
Tap any term to see what it means.
Knowledge check
0 of 5 answered
This self-assessment checks understanding of educational content only. It is not medical advice.
How this page was created
Cancer Explained does not originate medical claims. Every page restates guidance already published by the National Cancer Institute, the CDC, the USPSTF and the FDA, in plain language, with the source cited so you can check the original yourself. AI does the translating and organizing; automated checks test claims, citations, clarity and safety before anything publishes, and this is translation and navigation, not clinical judgment. Nothing here is personal medical advice, and no page can account for your particular situation.
Editorial status: Source checked — This page was written with AI assistance and then compared with the sources listed on it, looking for statements those sources do not back up. That check is not a sentence-by-sentence record and can miss errors. It is not a medical review, and it does not confirm the page is complete or right for your situation.
Human medical review: not completed. Pages here are not signed off by a clinician before they publish. That is not an oversight we are quietly working around: we restate published guidance and cite it, so the authority belongs to the source rather than to us, and every page names where its claims come from — you can verify us instead of trusting us. Where a volunteer clinician has reviewed a page, their name and credentials appear on it; where no name appears, no clinician has checked it. We are glad to have reviewers and are recruiting them, and we do not hold pages back waiting for one. Use this site to understand your situation and to ask better questions of the people treating you.
Read more about our editorial process, our use of AI, and our corrections policy.
Spotted a problem? Report an error — a factual mistake, broken or outdated source, confusing wording, or anything that seems unsafe. Please do not include names, medical record numbers, dates of birth, addresses, or other identifying medical information in your report.
After using this page, do you understand what to do next?
Anonymous — we only record the answer, never who gave it.