FDA Panel OKs Gene Test to Identify Patients for Herceptin Therapy

A U.S. Food and Drug Administration (FDA) advisory committee has endorsed a gene detection test that identifies women with metastatic breast cancer who could benefit from Herceptin therapy.

Genentech, Inc. announced that the Oncologic Drugs Advisory Committee of the FDA voted unanimously to recommend the inclusion of a fluorescence in situ hybridization (FISH)(PathVysion) test on the label of Herceptin® (trastuzumab).

Herceptin is a targeted monoclonal antibody treatment for women with HER2 positive metastatic breast cancer, a very aggressive form of the disease. Women must undergo special testing to see if they are HER2 positive and candidates for treatment with Herceptin.

"The power of personalized medicine is being able to identify -- in advance of treatment -- those patients most likely to respond to a particular therapy," said Dr. Robert Mass, associate director of Oncology at Genentech and presenter of the FISH research to the FDA panel.

"The importance of identifying appropriate patients is highlighted by the fact that Herceptin with chemotherapy demonstrated an increased survival benefit compared to chemotherapy alone for HER2 positive metastatic breast cancer patients in our pivotal trial," said Mass. "FISH testing can be an appropriate method that allows physicians to screen tumors with precision and helps ensure that each patient receives the treatment best-suited for their particular disease."

Other Sources: Genetech