Trastuzumab

Pharmacogenomic Information in the Context of the FDA-Approved Drug Label*

The FDA requires test results demonstrating HER2 protein overexpression prior to initiating therapy.

Excerpt from the trastuzumab drug label:

"Detection of HER2 protein overexpression is necessary for selection of patients appropriate for Herceptin therapy because these are the only patients studied for whom benefit has been shown. Assessment for HER2 overexpression and of HER2 gene amplification should be performed by laboratories with demonstrated proficiency in the specific technology being utilized. . . ."

HER2 (ERBB2) overexpression can be detected through an immunohistochemistry (IHC) test, which measures HER2 protein levels, or through fluorescence in situ hybridization (FISH), which assays gene amplification. For optimal diagnostic accuracy, it is advisable to use both types of testing. FDA-approved FISH assays include PathVysion(R) and HER2 FISH pharmDx(TM).

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the Trastuzumab drug label PDF.

Pharmacogenomic Diagnostic Testing

The information below is provided for educational purposes only and does not constitute an endorsement of any listed test or manufacturer.

¹ Entries in this column link to test manufacturer's website.
² Information in this column was found using searches of the entire FDA website (http://www.fda.gov/search.html), searches of the FDA CDRH CLIA database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/Search.cfm), or searches of the FDA CDRH Premarket Approval Database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm).

Table updated 4/15/2009.

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