FDA approves Genentech’s Itovebi for PIK3CA-mutated mBC

Swiss pharma giant Roche’s (ROG: SIX) US subsidiary Genentech has won much anticipated US regulatory approval of a new breast cancer drug.

The Food and Drug Administration (FDA) 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 around 40% of HR-positive metastatic breast cancers, Genentech noted.

The FDA approved this application seven weeks ahead of the agency’s goal date. The PI3K inhibitor was featured by Roche during its September investment day as a near-term value driver.