# FDA Approves Genentech's ITOVEBI (inavolisib) for PIK3CA-Mutant Breast Cancer Genentech announced FDA approval of ITOVEBI (inavolisib), an oral PI3K inhibitor for PIK3CA-mutant hormone receptor-positive breast cancer, positioning the company to compete in the growing precision oncology market alongside existing PI3K inhibitors. The approval expands Genentech's oncology portfolio and could capture significant market share from rival therapies in a patient population estimated at tens of thousands of women annually.