ITOVEBI

What it is

Itovebi contains inavolisib 3 mg or 9 mg as film-coated tablets.

Approved indications

— Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine therapy.

Dosing overview

The recommended dose of Itovebi is 9 mg taken orally once daily with or without food. Itovebi should be administered in combination with palbociclib and fulvestrant. Treatment of pre/perimenopausal women with Itovebi should also include a luteinising hormone-releasing hormone (LHRH) agonist in accordance with local clinical practice. For male patients, consider treatment with an LHRH agonist according to local clinical practice. Patients should be selected for treatment with Itovebi based on the presence of one or more PIK3CA mutations using a validated assay, and PIK3CA mutation status should be established prior to initiation of Itovebi therapy.

Key safety warnings

Before initiating treatment with Itovebi, fasting plasma glucose (FPG) or blood glucose (FBG) and HbA1c levels should be tested, and plasma or blood glucose levels should be optimised in all patients. After initiating treatment with Itovebi, patient fasting glucose levels should be monitored or self-monitored based on the recommended schedule. Renal impairment should be evaluated prior to treatment with Itovebi.

Regulatory history

Itovebi received approval on 2025-03-24. ARTG registration for Itovebi inavolisib 3 mg and 9 mg film-coated tablets was first listed on 2025-03-26.