SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY) announced that the European Commission has approved Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, to treat adults with PIK3CA-mutated, ER-positive, HER2-negative advanced breast cancer that has returned within 12 months of completing endocrine therapy.
In addition to the European Commission's approval, the Itovebi-based regimen is also approved for the treatment of adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer in the United States, Switzerland, Canada, Australia, United Arab Emirates, China and Taiwan, with data from INAVO120 under review with several other global health authorities.
Itovebi is currently being investigated in three company-sponsored phase III studies , all in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations. The company said it is exploring additional studies in breast cancer and other tumour types with the hope of providing the benefit of this targeted therapy to more people with PIK3CA mutations.
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