- 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.
- 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.