Roche (RHHBY) announced that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has adopted a positive opinion for 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. If approved, the Itovebi-based regimen has the potential to transform the standard of care in this first-line setting, where treatments are currently limited. A final decision regarding the approval is expected from the European Commission in the near future.
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