Genentech, a Roche Group member, announced FDA approval of Itovebi (inavolisib), in combination with palbociclib and fulvestrant, for adults with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated breast cancer. This new treatment targets patients whose cancer progressed after adjuvant endocrine therapy, addressing a key mutation found in 40% of HR-positive metastatic breast cancers. The regimen was shown to double progression-free survival compared to existing treatments.

The approval is based on the results of the INAVO120 Phase III study, which demonstrated a 57% reduction in the risk of disease progression or death. The combination of Itovebi with palbociclib and fulvestrant provided significant clinical benefits, with a manageable safety profile. This therapy offers a new standard for treating PIK3CA-mutated breast cancers, filling a gap in existing treatment options for this population.

The Itovebi-based regimen was granted FDA Priority Review and Breakthrough Therapy Designation in May 2024. Genentech is now evaluating further clinical applications of Itovebi through additional trials for breast cancer and other tumor types. Experts emphasize the importance of early biomarker testing to identify patients who may benefit from this targeted therapy.