The latest R&D and marketing trends of Inavolisib in 2025

As of2025, Inavolisib (Inavolisib, trade name: Itovebi) has made significant progress in the field of breast cancer treatment and became the first approved treatment forPIK3C API3Kα inhibitor for patients with mutated, ERpositive, HER2negative advanced breast cancer. Its approval is based on the positive results of the Phase III clinical trial of INAVO120, which provides patients with a new treatment option.

In July 2025, the European Commission approved Inavolisib in combination with palbociclib (palbociclib) and fulvestrant (fulvestrant) for the treatment of adult patients with PIK3CA mutated, ER positive, HER2 negative, locally advanced or metastatic breast cancer, especially those who relapse within 12 months of completing adjuvant endocrine therapy. The approval was based on data from the INAVO120 trial, which showed that the combination significantly extended progression-free survival and overall survival compared with traditional treatments.

As early as2024October, the U.S. Food and Drug Administration (FDA) has accelerated approval ofInavolisib< span>A combination regimen with palbocoxib and fulvestrist for the treatment of adult patients with endocrine-resistant, PIK3CAmutant, ERpositive, HER2negative, locally advanced or metastatic breast cancer. This approval provides new treatment options for patients, especially those for whom traditional treatments have had limited effectiveness.

INAVO120The Phase 3 clinical trial is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Inavolisib in combination with palboxib and fulvestrist. The trial results showed that the combination regimen of Inavolisib significantly prolonged progression-free survival and overall survival, and showed consistent efficacy in all preset subgroups. In addition, the patient's objective response rate and duration of response were also better than those in the placebo group.

Reference materials:https://www.drugs.com/