Roche secures FDA approval for breast cancer treatment

Roche’s Genentech has gained FDA approval for its drug inavolisib (Itovebi) when used in combination with palbociclib and fulvestrant for treating adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative advanced breast cancer. This approval provides a new therapeutic option for patients whose cancer has returned during or after adjuvant endocrine therapy, identified through an FDA-approved test.

The FDA’s decision was influenced by results from the INAVO120 trial, a randomized, double-blind study that included 325 patients with locally advanced or metastatic breast cancer. This study revealed that patients treated with inavolisib along with palbociclib and fulvestrant had a significant improvement in progression-free survival compared to those who received a placebo. Specifically, the median progression-free survival for patients on the combination therapy was 15 months, whereas it was only 7.3 months for the placebo group.

Additionally, the FDA has approved the FoundationOne Liquid CDx assay as a companion diagnostic tool to identify patients suitable for this treatment. The review and approval process for inavolisib was carried out under the FDA's Project Orbis initiative, which allows for simultaneous reviews of oncology treatments by international regulatory partners.