Application of monoclonal antibody (MoAb) technology to cancer management is discussed by reviewing the development and clinical evaluation of two MoAb‐based immunoscintigraphic agents (111In‐satumomab pendetide [OncoScint CR/OV‐In] and 111In‐CYT‐356; Cytogen Corporation, Princeton, NJ). Both agents were prepared using a site‐specific MoAb modification method that preserves the immunoreactivity of the radiolabeled immunoconjugate. 111In‐satumomab pendetide is an 111 In‐labeled conjugate of the murine MoAb B72.3, which is directed to TAG‐72, an antigen expressed by the majority of adenocarcinomas. By providing information that complements the results of standard radiographic diagnostic modalities, this imaging agent can aid in the treatment of patients with colorectal or ovarian cancer. Immunoscintigraphy with 111In‐satumomab pendetide has been shown to assist in medical‐surgical management by detecting occult extrahepatic lesions, clarifying equivocal results of other diagnostic imaging tests, and evaluating the extent and resectability of known tumor lesions. 111In‐CYT‐356 is an 111In‐labeled conjugate of the murine MoAb 7E11‐C5.3, which is reactive with prostatic carcinoma, benign prostatic hypertrophy, and, to a lesser extent, normal prostatic tissue. Results of preliminary clinical investigations suggest that 111In‐CYT‐356 immunoscintigraphy can be useful for the presurgical staging of prostatic carcinoma and for the detection of occult distant disease in patients with negative or equivocal results on standard imaging tests. Results with these site‐specifically radiolabeled immunconjugates demonstrate the clinical utility of MoAb‐based imaging agents in the treatment of patients with solid tumors.
111In-satumomab pendetide immunoscintigraphy was helpful in the medical and/or surgical management of 45 (44 percent) patients and provided information unavailable from other diagnostic modalities.
The premise of this paper is a concern over the dismal record of approvals for biotechnology products despite the enormous resources poured into their development.The authors have described a number of issues which may help to explain the dearth of biotechnology product approvals. Included among those issues are suggestions for improving the development process by ensuring the presence of several key resources which may be overlooked by emerging biotechnology companies. Particularly, the authors advocate creative approaches to development rather than relying too strongly on approaches used in the past. A s well, the authors suggest that applicants should intelligently use the resources of the Food and Drug Administration (FDA) for guidance and input into the development process. Finally, the authors suggest that when both applicants and FDA work smarter and faster, there will be many more approvals of biotechnology products.
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