NICE recommends neratinib for early HER2+ breast cancer

  • National Institute for Health and Care Excellence

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • The National Institute for Health and Care Excellence (NICE) newly recommends neratinib for routine use in HER2+ early breast cancer (eBCa) as in the National Health Service in England.
  • More specifically, neratinib is recommended as extended adjuvant therapy within 1 year after completion of adjuvant trastuzumab.
  • 2 conditions are attached to NICE's recommendation:
    • Trastuzumab must be the only HER2-directed therapy patients have received.
    • Patients must have had a residual invasive disease in the breast or axilla if (and after) they received neoadjuvant chemotherapy-based treatment.

Why this matters

  • Neratinib received European Commission marketing authorization in 2018, after publication of the ExteNET trial.

Key points

  • The 2 conditions attached to neratinib's approval reflect the absence of evidence from ExteNET for patients who received adjuvant pertuzumab in addition to trastuzumab and the exclusion of patients with a pathological complete response after chemotherapy-based neoadjuvant treatment.
  • ExteNET showed that across the entire study population, neratinib extended invasive disease-free survival by 27% (HR, 0.73; 95% CI, 0.57-0.92) and by 42% (HR, 0.58; 95% CI, 0.41-0.82) in the subgroup receiving neratinib within 1 year of completing trastuzumab therapy.
  • 40% of neratinib recipients had severe diarrhea, but this adverse event can be managed with diarrhea prophylaxis.