Nerlynx™

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

Questions?

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