European Commission Grants Approval to Roche’s Itovebi for Advanced Breast Cancer with PIK3CA Mutation
SHERIDAN, WYOMING – July 25, 2025 – Roche has received European Commission (EC) approval for Itovebi™ (inavolisib), a targeted therapy for adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer. The approval marks a significant milestone in the treatment of a subtype associated with poor prognosis and limited therapeutic options.
Regulatory milestone based on robust clinical evidence
The EC’s decision was driven by data from the pivotal phase III INAVO120 study, published in The New England Journal of Medicine in October 2024. The trial demonstrated that the Itovebi-based regimen—when used in combination with palbociclib (Ibrance®) and fulvestrant—more than doubled progression-free survival (15.0 months vs. 7.3 months; HR=0.43; p<0.001) compared with palbociclib and fulvestrant alone.