Trying Experimental Drugs to Treat Kidney Cancer
If you suffer from kidney cancer, you likely know that many drugs approved by the FDA for this condition don’t always work and their efficacy varies greatly from person to person. If you consider trying an experimental drug, understand first what it entails, and how you can have access to that drug.
FDA Approved Drugs vs. Experimental and Off-label Drugs
There are FDA-approved drugs for this kidney cancer, which had been extensively tested in animal and human studies and have been deemed to be safe and effective. The drug label of an FDA approved drug will provide information about the medication including the dosage and the condition(s) for which it has been approved.
Experimental drugs are still being evaluated to determine whether they are safe and effective in treating a specific condition. An “off-label “drug (also called unapproved) defines a drug that may be approved by the FDA for certain diseases, yet is used for different medical conditions. For example, a chemotherapy drug may be approved for one type of cancer, and yet is described as an off-label drug for kidney cancer. The off-label drugs are used because researchers believe that medication may help you; the marketers of the drug did not complete the studies required by the FDA to officially approve the drug for your condition.
Before Trying the Drug
Before starting a new therapy with an experimental or off-label drug, talk to your specialist and try to find answers to the following questions:
- Did you try all the FDA approved drugs for your condition, or is there any other medication you should use before trying an experimental drug?
- Is there information available to indicate that the new drug can help treat kidney cancer?
- Are you a suitable candidate for this drug?
- Does the new drug have the potential to help you more that the regular FDA approved drugs?
- What are the risks and benefits of this experimental/off-label drug?
- What is the cost of the drug? Would that drug be covered by your health insurance plan?
- If the drug helps you, can you continue to use it after the study is completed? If so, what would it cost?
How to Gain Access to an Experimental Drug
Talk to your specialist and search for studies that are currently recruiting participants. The investigators (researchers) will provide details about selection criteria, and what the study involves. In many cases the medication is free of charge, as Government agencies and drug developers cover it; you may be compensated for your time, travel and other expenses. If you are not a suitable candidate to participate in a study, you may still have access to the new treatment through a program called the Expanded Access Program.