New Hope for Breast Cancer: Itovebi by Roche gets EU Approval
PharmaGenDrx News Bureau – July 27, 2025
10:00 AM IST
On July 24, 2025, The Roche announced that the European Comission has approved an oral treatment targeted towards adult patients suffering from locally advanced or metastatic breast cancer. Itovebi (inavolisib) in combination with the palbociclib (Ibrance) and fulvestrant, offers a noble mechanism of action, by breaking down the mutated PI3K alpha protein responsible for cancer growth in about 40% ER-positive cases; making it safer and more precise as compared to the previously used drug that bore major side-effects.
This approval also applies to patients who have experienced recurrence during or within 12 months after finishing endocrine therapy. This approval is based on the results of the Phase III INAVO120 trial wherein Itovebi cuts cancer progression by 57%, lowers death risk 33% and delays the need of chemotherapy by 2 years approximately.
Even though evaluations are still ongoing the therapy is already approved in countries like USA, Canada, Australia, China, Taiwan, Switzerland and UAE and is under regulatory review in other countries.
According to Dr. Levi Garraway, Roche’s chief medical officer this treatment is the first of its kind to improve survival outcome and address a major unmet need in this subgroup of breast cancer.
