Neratinib maleate

(Nerlynx®)

Nerlynx®

Drug updated on 5/17/2024

Dosage FormTablet (oral; 40 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
  • Indicated in combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

Summary
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  • Neratinib maleate (Nerlynx) is indicated as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy. Additionally, it is utilized in combination with capecitabine for treating adults with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
  • The information was derived from six systematic reviews and meta-analyses that focus on comparing Nerlynx to other treatment options regarding safety and effectiveness.
  • In terms of efficacy and safety comparison, neratinib-containing regimens rank favorably for reducing CNS disease progression while underlining the superiority of antibody-drug conjugates (ADCs) in survival outcomes. However, when compared among various treatments used alone, it showed less favorable outcomes for overall survival benefits.
  • For population types and subgroup considerations, neratinib demonstrates effectiveness in patients with CNS involvement and early breast cancer when combined with another HER2-targeted therapy. This suggests its benefits could be maximized for specific subgroups, such as those having brain metastases or post-trastuzumab-based therapy.
  • Trastuzumab plus neratinib is preferred due to substantial efficacy and lower toxicity, especially highlighted in the context of adjuvant treatment for early breast cancer, giving a specific context where this drug combination demonstrates a favorable balance between efficacy and safety.
  • Neratinib offers potential advantages including a lower likelihood of causing severe adverse events compared to some other drugs like T-DXd, although generally, T-DXd has been favored over neratinib based on overall survival, progression-free survival, and safety endpoints according to one study reviewed.

Product Monograph / Prescribing Information

Document TitleYearSource
Nerlynx (neratinib maleate) Prescribing Information2022Puma Biotechnology, Inc., Los Angeles, CA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines