Radioimmunotherapy as front-line therapy
Betsy has written of a patient who recently received Bexxar as front-line therapy in the treatment of lymphoma.
Firstly, what does "front-line" mean? Simply, the patient has not received any prior therapy for his or her disease. Front-line therapy is the first therapy.
Secondly, one must be cognizant that Zevalin and Bexxar are approved for therapy of recurrent or resistant lymphoma.
Thirdly, and importantantly, while these agents are not formally approved by the Food and Drug Administration for front-line therapy, nonetheless, they may be used ETHICALLY AND LEGALLY by radiation oncologists and nuclear medicine physicians as front-line therapy.
Why?
The US Food and Drug Administration regulates and controls new drugs that may be used by physicians. These controls include the medical indications for which a medication may be used. Since Zevalin and Bexxar are approved drugs for treatment of lymphoma, the physician may use these agents "OFF-LABEL" meaning that the physician has judged that the indication for the medicine extends to front-line therapy.
Off-label use of medications is common and long-standing in medical practice. One of the most important medicines in the treatment of heart attacks was used for years in off-label fashion.
I, personally, in early 2003 received Zevalin (with wonderful results) as front-line therapy in an experimental clinical trial. Today, a patient may receive Zevalin "off-label" as front-line therapy if the treating physician and patient agree to this therapeutic plan. The patient need not enter an experimental clinical trial.
Again, off-label use of radioimmunotherapy is both ethical and legal. Newly diagnosed patients should consult with a radiation oncologist or nuclear medicine physician to learn whether front-line therapy is a prudent option.
Mort