Table 1.

The FDA Indications and Usage of Pertuzumab in HER2-positive Breast Cancer (2020)

Individual selection*Metastatic breast cancer (treatment)Breast cancer (neoadjuvant treatment)Early breast cancer (adjuvant treatment)
Tumor HER2 statusHER2-positiveHER2-positiveHER2-positive
UsageUse pertuzumab with trastuzumab and docetaxelUse pertuzumab with trastuzumab and chemotherapy
IndicationsIndicated for individuals with metastatic breast cancer who have not received before anti-HER2 therapy or chemotherapy for metastatic diseaseIndicated for individuals with locally advanced, inflammatory, or early-stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a treatment regime for early breast cancerIndicated for individuals with early breast cancer at high risk of recurrence
*

Select individuals based on HER2 protein overexpression or HER2 gene amplification in tumor specimens. Assessment of HER2 protein overexpression and ERBB2 gene amplification should be performed using FDA-approved tests specific for breast cancer by laboratories with demonstrated proficiency. Information on the FDA-approved tests for the detection of HER2 protein overexpression and ERBB2 gene amplification is available at: http://www​.fda.gov/CompanionDiagnostics.

Improper assay performance, including use of sub optimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.

This FDA table was created from (1).

From: Pertuzumab Therapy and ERBB2 Genotype

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