We’re experiencing issues with our datasets and search. We apologise for any inconvenience while we work to fix this.
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.