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HER2 Gene Test Information Included in Trastuzumab Labeling

HER2 Gene Test Information Included in Trastuzumab Labeling

Received approval from the US Food and Drug Administration (FDA) to include
information about Abbott’s PathVysion—a fluorescence in situ hybridization
(FISH) test—in the product insert for trastuzumab (Herceptin). FISH is
used to detect human epidermal growth factor receptor 2 (HER2) gene
amplification 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 Cancer
Research, Department of Pathology, Norris Comprehensive Cancer Center,
University of Southern California. "Gene amplification, as determined by
FISH, provides the most accurate method for diagnosing HER2 status, permitting
those women with the molecular target for Herceptin to be most appropriately

Mortality and Morbidity Rates Improve

In addition, the new information in the product insert shows that patients
enrolled in Genentech’s pivotal trials whose tumors demonstrated HER2 gene
amplification benefited from treatment with trastuzumab. In a retrospective
analysis, patients who received standard chemotherapy and were selected by FISH
for additional therapy with trastuzumab had a 30% decrease in the risk of death
and a 56% decrease in the risk of disease progression compared to patients who
were treated with chemotherapy alone.

"Herceptin is one of the first examples to demonstrate the benefits of a
targeted medicine," said Gwen Fyfe, md, Genentech’s senior director of
oncology, medical affairs. "In our pivotal trial, Herceptin in combination
with chemotherapy demonstrated an increased survival benefit compared to
chemotherapy alone, demonstrating the importance of identifying appropriate
candidates for Herceptin therapy."

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

Greater Awareness of Test


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