Off-Label Chemotherapy Use

Off-label use

An FDA approval implies that the drug can now be used to treat a specific condition when it is administered in the manner described on the drug’s label. Further clinical research may be required to study other potential uses of the drug, for example, to treat a different form of cancer. An off-label use of the drug is said to have occurred when an FDA-approved drug is prescribed by a doctor to treat conditions that are not mentioned on the label or in a manner that is not described on the label. There are many reasons as to why it is a common practice to use off-label drugs to treat cancer. Firstly, drugs are usually approved for the treatment of a specific form or stage of cancer. Once approved, a drug that effectively treats a specific form of cancer is often identified as an effective treatment for other types of cancer as well. Secondly, there are certain cancers that necessitate the use of multiple drugs. In that case, one or more drugs are often used off label. Treatment regimens involving multiple drugs are also evolving constantly, as doctors evaluate new drug combinations to improve the quality of patient care.

Getting FDA approval for new labeling information

In order to get FDA approval for new labeling information meant for an existing drug (FDA approved), the drug sponsor should file a supplemental marketing application with the FDA. This is done to ensure the drug’s safety and effectiveness, as relevant to the new labeling information. In certain cases, the sponsor may find out that the information required to file a supplemental application is not as extensive as may be necessary for initial approval. The FDA has launched a variety of initiatives to encourage supplemental applications involving products used in the treatment of cancer. For instance, the FDA constantly interacts with academic, private and professional groups engaged in cancer-related research and treatment. After obtaining their views about off-label drug, the FDA then contacts drug sponsors to assist in the supplemental application submission process.