Roche’s Genentech has received FDA approval for inavolisib (Itovebi) in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, advanced breast cancer.
The approval is intended for patients whose disease recurred on or after completing adjuvant endocrine therapy, as determined by an FDA-approved test, offering a new treatment option for this challenging condition.
The decision is based on findings from the INAVO120 trial, a randomized, double-blind study involving 325 patients with locally advanced or metastatic breast cancer. The trial demonstrated a significant increase in progression-free survival for those treated with inavolisib alongside palbociclib and fulvestrant compared to the placebo group. Patients receiving the combination therapy experienced a median progression-free survival of 15 months, compared to 7.3 months for those in the placebo group.
The FDA also approved the FoundationOne Liquid CDx assay as a companion diagnostic tool to identify patients eligible for this treatment. The review was conducted under the FDA’s Project Orbis initiative, which facilitates concurrent reviews of oncology drugs among international partners.
