AUTHORIZATION TO INSERT a gene into humans is imminent. It only remains for James B. Wyngaarden, MD, National Institutes of Health (NIH) director, and Frank E. Young, MD, Food and Drug Administration (FDA) commissioner, to give approval, which they are expected to do this month.
The numerous reviews are an indication of the care with which this proposal was considered (JAMA 1988;260:2783). Even though "it does not constitute gene therapy per se, it must be regarded as a prelude to such experiments," Wyngaarden has noted.
The work involves placing the gene for neomycin resistance into tumorinfiltrating lymphocytes as a marker for following the fate of these cells when they are injected into cancer patients. The use of the gene is not directly therapeutic, although the goal is an improved antitumor regimen.
The tumor-infiltrating lymphocytes are cultures of cells obtained from the patient's tumor and subsequently injected back into the patient.