Nerlynx (neratinib) — Medica
Breast cancer – recurrent or metastatic HER2-negative disease with HER2-activating mutation
Initial criteria
- age ≥ 18 years
- HER2-negative breast cancer
- presence of a HER2-activating mutation (e.g., L755S, D769H/Y, V777L, exon 20 insertion)
- EITHER postmenopausal female or male OR pre/perimenopausal female with ovarian suppression/ablation with GnRH agonist (e.g., leuprolide, triptorelin, goserelin) or surgical bilateral oophorectomy or ovarian irradiation
- EITHER hormone receptor–positive disease AND tried at least one CDK4/6 inhibitor (e.g., ribociclib, palbociclib, abemaciclib) OR hormone receptor–negative disease
Approval duration
1 year