The U.S. Food and Drug Administration (FDA) has approved Itovebi (inavolisib), a targeted therapy for adults with advanced or metastatic hormone receptor-positive, HER2-negative breast cancer carrying a PIK3CA mutation.
This decision is based on findings from the Phase III INAVO120 trial, which demonstrated that the Itovebi regimen, when combined with palbociclib and fulvestrant, significantly extended progression-free survival compared to treatment with palbociclib and fulvestrant alone.
The INAVO120 study, which supported the approval, involved patients whose breast cancer had recurred or progressed following adjuvant endocrine therapy.
The Itovebi-based treatment reduced the risk of disease progression or death by 57%, with a median progression-free survival of 15 months compared to 7.3 months for the control group.
Although overall survival data is still maturing, early indications show a promising trend favoring the Itovebi regimen.
The FDA granted Itovebi Priority Review and Breakthrough Therapy Designation, and Roche plans to make the drug available in the U.S. soon. Global regulatory filings are also underway, including submissions to the European Medicines Agency.
Beyond INAVO120, Roche is exploring the potential of Itovebi in additional clinical trials (INAVO121 and INAVO122) to evaluate its effectiveness in various combinations for different stages of HR-positive, PIK3CA-mutated breast cancer.
Hormone receptor-positive breast cancer is the most common form of the disease, accounting for approximately 70% of all cases. Tumors of this type are driven by hormones like estrogen and progesterone, and the PIK3CA mutation in HR-positive cancers is linked to resistance to current treatments, highlighting the importance of novel therapies like Itovebi.
With this approval, Roche aims to offer more personalized and effective treatment options for people with breast cancer, particularly those whose disease is driven by genetic mutations like PIK3CA.
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