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Genentech Herceptin diagnostic test

Executive Summary

Labeling for Genentech's breast cancer treatment Herceptin adds information on Abbott/Vysis'PathVysion fluorescence in situ hybridization (FISH) test for selecting patients for therapy, following FDA approval of Genentech's sBLA Aug. 29. FDA's Oncologic Drugs Advisory Committee unanimously recommended approval of the label change, but said labeling should emphasize a lack of data indicating FISH is beneficial in selecting patients (1"The Pink Sheet" Dec. 10, 2001, p. 30). Labeling notes that data are inconclusive as to whether "FISH testing can distinguish a subpopulation of CTA 2+ patients who would be unlikely to benefit from Herceptin therapy"...

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