FDA approves inavolisib (Itovebi) in combination with palbociclib and fulvestrant for locally advanced, PIK3CA-mutated, HR-positive/HER2-negative breast cancer. INAVO120 trial showed inavolisib more than doubled median progression-free survival (PFS) to 15 months from 7.3 months. Common adverse events include neutrophil, hemoglobin, and platelet decreases, and increases in fasting glucose and creatinine.