Orserdu (elacestrant) — Medica
Breast cancer, estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated advanced or metastatic, with disease progression following endocrine therapy
Initial criteria
- age ≥ 18 years
- Patient has recurrent or metastatic disease
- Estrogen receptor-positive (ER+) disease
- HER2-negative disease
- ESR1-mutated disease
- Tried at least one endocrine therapy (e.g., fulvestrant, anastrozole, exemestane, letrozole, tamoxifen)
- Patient is a postmenopausal woman or man OR patient is a pre/perimenopausal woman receiving ovarian suppression/ablation with a GnRH agonist (e.g., leuprolide acetate, triptorelin pamoate, goserelin acetate) OR patient has had surgical bilateral oophorectomy or ovarian irradiation
Approval duration
1 year