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Genentech Herceptin adds FISH test

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genentech's sBLA to add fluorescence in situ hybridization (FISH) testing to Herceptin (trastuzumab) labeling clears FDA Aug. 28. The approval also adds data showing that patients testing positive on FISH benefited from the HER-2 breast cancer treatment. "In a retrospective analysis, patients selected using FISH testing treated with Herceptin in addition to standard chemotherapy had a 30% decrease in the risk of death and a 56% decrease in the risk of disease progression compared to patients treated with chemotherapy alone," the company said. Labeling already listed immunohistochemistry (IHC) as a diagnostic method of detecting HER-2 positive patients. FDA's Oncologic Drugs Advisory Committee unanimously recommended inclusion of the PathVysion FISH assay in Herceptin labeling in December 2001. The sBLA was submitted in March 200

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