Itovebi (inavolisib) — Medica

Initial criteria

• age ≥ 18 years
• Patient is a postmenopausal female OR (patient is a pre/perimenopausal female or a male AND receiving a gonadotropin-releasing hormone (GnRH) agonist OR has had surgical bilateral oophorectomy/ovarian irradiation (female) or orchiectomy (male))
• Patient has locally advanced or metastatic hormone receptor (HR)-positive disease
• Patient has human epidermal growth factor receptor 2 (HER2)-negative disease
• Patient has PIK3CA-mutated breast cancer as detected by an approved test
• Patient has disease progression while on adjuvant endocrine therapy OR recurrence within 12 months after completing adjuvant endocrine therapy
• Medication will be used in combination with Ibrance (palbociclib) and fulvestrant injection

Approval duration

1 year