HER2 Gene Test Information Included in Trastuzumab Labeling

Received approval from the US Food and Drug Administration (FDA) to includeinformation about Abbott’s PathVysion—a fluorescence in situ hybridization(FISH) test—in the product insert for trastuzumab (Herceptin). FISH isused to detect human epidermal growth factor receptor 2 (HER2) geneamplification in a patient’s breast cancer cells.

"This is promising news for both patients and physicians alike,"said Michael Press, md, phd, the Harold E. Lee Chair Professor for CancerResearch, Department of Pathology, Norris Comprehensive Cancer Center,University of Southern California. "Gene amplification, as determined byFISH, provides the most accurate method for diagnosing HER2 status, permittingthose women with the molecular target for Herceptin to be most appropriatelytreated."

Mortality and Morbidity Rates Improve

In addition, the new information in the product insert shows that patientsenrolled in Genentech’s pivotal trials whose tumors demonstrated HER2 geneamplification benefited from treatment with trastuzumab. In a retrospectiveanalysis, patients who received standard chemotherapy and were selected by FISHfor additional therapy with trastuzumab had a 30% decrease in the risk of deathand a 56% decrease in the risk of disease progression compared to patients whowere treated with chemotherapy alone.

"Herceptin is one of the first examples to demonstrate the benefits of atargeted medicine," said Gwen Fyfe, md, Genentech’s senior director ofoncology, medical affairs. "In our pivotal trial, Herceptin in combinationwith chemotherapy demonstrated an increased survival benefit compared tochemotherapy alone, demonstrating the importance of identifying appropriatecandidates for Herceptin therapy."

Genentech submitted its supplemental biological license application to theFDA for the product insert change in March 2001. In December 2001, the OncologicDrugs Advisory Committee to the FDA voted unanimously to recommend including thePathVysion FISH assay in the Herceptin package insert. The trastuzumab packageinsert now includes information on both FISH and immunohistochemistry asappropriate methods for identifying HER2-positive patients.

Greater Awareness of Test

"We’re pleased by the FDA’s decision to include PathVysion as partof Herceptin’s label and believe it opens the door for this important test tobecome more widely used in the selection of appropriate therapy for women withbreast cancer," said Edward L. Michael, vice president, DiagnosticCommercial Operations, Abbott Laboratories. "Currently there are 168 labstrained and performing PathVysion assays, which provides us access to 73% of allHER2 testing for breast cancer. With the new Herceptin label, we anticipate evengreater awareness of this test among health-care professionals."

In January 2002, the FDA granted Abbott approval to include Herceptin inPathVysion’s label, making it the only HER2 product to have three claims:prognosis, doxorubicin-based therapy selection, and trastuzumab therapyselection.