ITOVEBI (Roche Products Pty Ltd)
Product name
ITOVEBI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
161 (255 working days)
Active ingredients
inavolisib
Registration type
NCE/ NBE
Indication
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.