FDA Approves Inavolisib for Advanced PIK3CA-Mutated Breast Cancer

On Oct. 10, 2024, the U.S. Food and Drug Administration approved inavolisib (brand name: Itovebi) in combination with Ibrance (chemical name: palbociclib) and Faslodex (chemical name: fulvestrant) to treat advanced stage or metastatic hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. The cancer has to have grown during hormonal therapy treatment or come back after hormonal therapy ended.

Inavolisib is a type of targeted therapy medicine called a PI3K inhibitor. Previously, Piqray (chemical name: alpelisib) was the only PI3K inhibitor approved to treat breast cancer with a PIK3CA mutation. This approval means that people with breast cancer with this mutation now have another option.

The approval was based on results from the INAVO120 study. The study compared the combination of inavolisib, Ibrance, and Faslodex to just Ibrance and Faslodex and found adding inavolisib to Ibrance and Faslodex more than doubled progression-free survival — from 7.3 months to 15 months. Progression-free survival is how long people live without the cancer growing.

The most common side effects of inavolisib are high blood sugar, mouth sores, and diarrhea.