The European Commission has cleared Roche’s Itovebi (inavolisib) for use with palbociclib and fulvestrant in adults whose PIK3CA-mutated, oestrogen-receptor-positive, HER2-negative advanced breast cancer has recurred within a year of endocrine therapy. In the Phase III INAVO120 study the PI3K inhibitor cut the risk of disease progression or death by 57%, extending median progression-free survival to 15.0 months from 7.3 months for the control arm. Final analysis showed a 33% reduction in overall mortality and delayed the need for chemotherapy by roughly two years. Itovebi is the first PI3K-targeted medicine approved in Europe to show a survival benefit in this common breast-cancer subtype, which accounts for up to 40% of hormone-receptor-positive cases. The decision follows clearances in the United States and several other markets and strengthens Roche’s position in solid-tumour therapeutics. Separately, the company secured a CE Mark for its Elecsys pTau181 blood test, developed with Eli Lilly. The assay demonstrated a 93.8% negative predictive value in ruling out Alzheimer’s disease, potentially allowing clinicians to reduce the number of costly and invasive confirmatory procedures. The dual approvals expand Roche’s oncology and diagnostics portfolios ahead of its half-year earnings report later this week.