cies (e.g., DOE, NIH, FDA) to discuss standardization, validation, and pathways for establishing surrogate markers of clinical response.

4.6
CONCLUSIONS

As noted earlier, targeted radionuclide therapy has the promise to personalize treatment by tailoring the properties of the radionuclide and the targeting vehicle for each patient. BEXXAR® and Zevalin® demonstrate robust proof of principle that adding a radionuclide enhances the clinical efficacy when compared with treating the patient with the biologic agent (e.g., cold antibody) alone. In addition, targeted radiotherapeutics have the potential for treating patients at a lower cost and with less morbidity than more standard treatment procedures. For example, radiation synovectomy is an alternative to surgery for the treatment of rheumatoid arthritis that costs less and allows patients to return to normal life sooner. It is a relatively simple procedure that can be performed on an outpatient basis and that is under ongoing investigation in Europe, although the approach is relatively dormant in the United States.

Recent experience in Europe demonstrates the appeal of targeted radionuclide therapy to patients. Patients increasingly go to Europe to receive targeted radionuclide therapy treatments that are not available domestically, and the gap in technology is increasing. The French are constructing a consortium-funded, high-yield, and versatile cyclotron for radionuclide production that will become operational in 2008. Such a machine has been under discussion for more than 10 years in the United States, and if anything, we are further away than we were a decade ago from constructing this critical piece of infrastructure. For the United States to retain its status as a leader in the field, these hurdles will need to be addressed.



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