Posted by Michael Wonder on 23 Jul 2025
European Commission approves Roche’s Itovebi for people with ER positive, HER2 negative, advanced breast cancer with a PIK3CA mutation
23 July 2025 - Approval based on INAVO120 data showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone.
Roche announced today that the European Commission has approved Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor positive, human epidermal growth factor receptor 2 negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.
