FDA posts Herceptin sBLA review

The FDA on Tuesday posted its review of an sBLA from Genentech (DNA) in advance of Wednesday's Oncologic Drugs Advisory Committee meeting. The sBLA seeks to add information on use of a fluorescence in situ hybridization (FISH) assay to detect gene amplification to the label of DNA's Herceptin trastuzumab anti- HER2 antibody for metastatic breast cancer.

In DNA's studies, the company used PathVysion, a FISH assay from Vysis (VYSI). PathVysion is approved for prognosis and assessment of a patient for anthracycline therapy, but is not indicated as an aid in selecting patients for Herceptin treatment. ...