
SILVER SPRING, Maryland-The FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously recommended that the agency amend the labeling of Herceptin (trastuzumab, Genentech) to include a new gene-detection test to identify women with metastatic breast cancer who are likely to benefit from the therapy. The 16-to-0 vote backed adding the PathVysion HER-2 DNA Probe Kit to the labeling. The kit is made by Vysis, Inc., now owned by Abbott Laboratories.
