Roche (RHHBY) announced that the European Commission has approved Itovebi, in combination with palbociclib and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. These results were reinforced by the INAVO120 final overall survival analysis that showed the Itovebi-based regimen reduced the risk of death by 33%. Additionally, the treatment regimen substantially delayed the time to chemotherapy by approximately two years compared with palbociclib and fulvestrant alone.
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