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European Commission approves Roche’s Itovebi for people with ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation
Globenewswire·2025-07-23 05:00

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][6]. Summary by Sections Approval and Efficacy - The approval is based on the phase III INAVO120 trial, which demonstrated a 57% reduction in the risk of disease progression or death with the Itovebi-based regimen compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; HR=0.43; p<0.001) [2][3]. - The final overall survival analysis from the INAVO120 study indicated a 33% reduction in the risk of death (stratified HR=0.67; p=0.0190) and delayed the time to chemotherapy by approximately two years compared to the control group [3][9]. Treatment Characteristics - Itovebi is an oral, targeted therapy designed to minimize treatment burden and toxicity, showing high potency and specificity for the PI3K alpha isoform [5][8]. - The treatment is well-tolerated, with no new safety signals reported during the trials [2][3]. Ongoing Research - Beyond INAVO120, Itovebi is being investigated in three additional phase III studies (INAVO121, INAVO122, INAVO123) for various combinations in PIK3CA-mutated breast cancer [4][10]. - The company is exploring further studies in breast cancer and other tumor types to expand the benefits of this targeted therapy [4][10]. Market Context - Up to 40% of ER-positive breast cancers have a PIK3CA mutation, which is associated with poor prognosis, highlighting the urgent need for effective treatment options [8][11]. - Roche has been a leader in breast cancer research for over 30 years, focusing on identifying new biomarkers and treatment approaches for various subtypes, including ER-positive breast cancer [12][13].