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FDA's Biological Response Modifiers Advisory Committee

Executive Summary

Will meet Jan. 16-17. On the first day, Cytogen's OncoScint OV 103 for the diagnosis of primary and recurrent ovarian carcinoma will be reviewed. OncoScint is the first Cytogen product to come before an advisory committee. On Jan. 17, the committee will discuss for the second time, Cetus' Proleukin (interleukin-2) for the treatment of metastatic renal cell carcinoma. In July 1990, the committee suggested that Cetus reanalyze its efficacy data and conduct new studies ("The Pink Sheet" Aug. 6, 1990, p. 6). The company complied and supplied the results of its reanalysis to FDA in December 1990. The meeting, at the Bethesda, Md. Holiday Inn, 8120 Wisconsin Ave. will begin at 10 a.m. on the 16th and at 8:30 a.m. the following day. The committee also will meet in a closed session on Jan. 17.

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