Off-label Drug Use in Cancer Therapy
The United States Food and Drug Administration (FDA) regulates and controls new drugs that may be used by physicians. These controls include the medical indications for which a medication may be used.
For example, the radioimmunotherapy agent Zevalin is FDA-approved for the treatment of relapsed or refractory non-Hodgkin's lymphoma. Off-label use of Zevalin means that this approved medication would be used by a lymphoma specialist as first-line therapy of NHL rather than for relapsed or end-stage patients.
Off-label use of medications is very common in medical practice, particularly in treatment of patients who have cancer. Interestingly, one of the most important medicines used in the treatment of heart attack patients was used off-label for years.
Off-label use of a medication is legal and ethical.
My suggestion to newly diagnosed NHL patients: consult with a physician experienced in radioimmunotherapy (RIT) and enquire whether RIT may be properly and effectively used off-label in your therapy.
In the clinical trial in which I was a patient, I received RIT off-label as first-line therapy of NHL. My results are superlative.
Mort