Living with cancer blog
Compassionate use of experimental drugs possible in cancer treatment
By Sheryl M. Ness, R.N. September 1, 2012
Every week, new experimental drugs are in the news for cancer treatment. The process of studying and approving a new cancer drug from start to finish can take many years. In certain situations, the Food and Drug Administration (FDA) gives permission to companies to provide new experimental drugs to people outside of the clinical trial process. This is usually called compassionate use of a drug.
In order for you to receive the experimental drug with the compassionate use program, your doctor must contact the drug company as well as submit an application to the FDA. There are strict criteria that must be present in order for you to be approved.
- You have advanced cancer.
- You have used standard treatments and they have not worked for you.
- You aren't eligible for clinical trials using the experimental drug.
- You have no other treatment options available, and your doctor believes that you'd benefit from the experimental drug.
- The company that makes the drug agrees to provide it to you.
Keep in mind that even if you're approved to receive the experimental drug, you may experience unknown side effects and you may not benefit from treatment.
Also, not all drug companies agree to give access to experimental drugs through this process. Be informed about the costs — the drug company may charge you for the experimental drug and your insurance company may deny coverage of experimental drugs.
Another way to gain access to experimental treatments is to look for expanded access studies. To find studies, search for the term — expanded access studies — on ClinicalTrials.gov. For more information on the FDA process for compassionate use of drugs, visit the FDA website (www.fda.gov/Drugs/default.htm).
Sept. 01, 2012
Sheryl M. Ness, R.N.