Genentech Herceptin diagnostic test
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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Genentech's Herceptin (trastuzumab) labeling should add information about use of Vysis' PathVysion fluorescence in situ hybridization (FISH) test as an aid in selecting patients for therapy with the breast cancer drug, FDA's Oncologic Drugs Advisory Committee concluded Dec. 5
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