By Fineline Cube 
Swiss giant Roche AG (SWX: ROG, OTCMKTS: RHHBY) announced that its Itovebi (inavolisib) has been recommended for market approval by the European Medicines Agency’s Medicinal Products for Human Use (CHMP). The recommendation supports the use of Itovebi in combination with palbociclib and fulvestrant for adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.
Clinical Trial Results
The recommendation is based on results from the phase III INAVO120 study, 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) in the first-line setting. Additionally, the Itovebi-based regimen was well tolerated, with no new safety signals observed.-Fineline Info & Tech