Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration approved Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers.
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