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Drug - Nerlynx™ (neratinib) [Puma Biotechnology Inc.]

February 2018

Therapeutic area - Oral Oncology

Approval criteria

  • Patient must be at least 18 years old AND
  • Patient must have a diagnosis of early stage (i.e., stage 1-3) HER2-positive overexpressed/amplified breast cancer AND
  • HER2 overexpression must be confirmed as follows:
    • Immunohistochemistry (IHC) assay 3+ OR
    • Fluorescence in situ hybridization (FISH) Assay ≥ 2.0 (HER2/CEP17 ratio) OR
    • Average HER2 copy number ≥ 6 signals/cell AND
  • Documented adjuvant trastuzumab-based therapy within the preceding two years AND
  • Nerlynx must be used as a single agent AND
  • Prescriber must attest that patient will receive reproductive health counseling 

Quantity limits

  • 204 tablets per 34 days
  • Duration of therapy is limited to one year


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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