European Commission approves Roche's Itovebi for people with ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation

Approval based on INAVO120 data showing the Itovebi™ (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone1 Up to 40% of ER-positive breast cancers have a PIK3CA mutation and are associated with poor prognosis; this approval helps address an urgent unmet need2-4Itovebi is the first PI3K-targeted therapy to significantly extend survival, reinforcing the need for biomarker testing at diagnosis5 Basel, 23 July 2025 - Roche (SIX: RO, ROG; OTCQX: R ...