FDA Grants Breakthrough Therapy Designation to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation

Genentech announced that the US FDA has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.