FDA Approves Itovebi

On October 10, 2024, the FDA approved inavolisib (Itovebi^TM, Genentech, Inc.) with palbociclib (Ibrance®) and fulvestrant (Faslodex®) and a companion diagnostic test for the treatment of people with hormone-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative MBC after completion of hormone therapy or after their cancer comes back. This approval is based on results from the phase III INAVO120 clinical trial.

Inavolisib (Itovebi^TM) for HR+, HER2- MBC

• US Food and Drug Administration: FDA approves inavolisib (Itovebi^TM) with palbociclib (Ibrance®) and fulvestrant (Faslodex®) for hormone-resistant, PIK3CA-mutated, HR-positive, HER2-negative MBC
• Foundation Medicine: An FDA-approved companion diagnostic test can be used to identify patients who are eligible for inavolisib (Itovebi^TM)

Clinical Trials for Inavolisib (Itovebi^TM)

• Metastatic Trial Search: MBC Trials for Inavolisib (Itovebi^TM)

• Category: Special Topics
• Tag: FDA Approval