Core Viewpoint - Roche's Itovebi™ (inavolisib) has received European Commission approval for treating adult patients with PIK3CA-mutated, ER-positive, HER2-negative advanced breast cancer, addressing a significant unmet medical need [1][2]. Group 1: Treatment Efficacy - The approval is based on the phase III INAVO120 trial, which demonstrated a 57% reduction in the risk of disease worsening or death (progression-free survival [PFS]) with the Itovebi-based regimen compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43; 95% CI: 0.32-0.59, p<0.001) [2][6]. - The Itovebi-based regimen also reduced the risk of death by 33% in the final overall survival analysis (stratified HR=0.67; 95% CI: 0.48–0.94, p-value=0.0190) [2][6]. - The treatment delayed the time to chemotherapy by approximately two years compared to the control regimen (stratified HR=0.43; 95% CI: 0.30-0.60) [2][6]. Group 2: Ongoing Research and Development - Itovebi is currently being investigated in three additional phase III studies (INAVO121, INAVO122, INAVO123) for various combinations in PIK3CA-mutated, locally advanced or metastatic breast cancer [3][7]. - The company is exploring further studies in breast cancer and other tumor types to expand the benefits of this targeted therapy [3]. Group 3: Product Characteristics - Itovebi is an oral, targeted treatment designed to provide durable disease control with minimized overall burden and toxicity, specifically targeting the PI3K alpha isoform [4][6]. - The treatment is approved in multiple countries, including the United States, Canada, and Australia, with ongoing reviews by other global health authorities [4]. Group 4: Market Context - Approximately 40% of ER-positive breast cancers have a PIK3CA mutation, which is associated with poor prognosis, highlighting the urgent need for effective treatment options [6][8]. - Roche has been advancing breast cancer research for over 30 years, focusing on identifying new biomarkers and treatment approaches for various subtypes, including ER-positive breast cancer [9].