FDA Approves Roche's Itovebi Combo for Advanced Breast Cancer

Roche has announced that its PI3K inhibitor, Itovebi (inavolisib), has been approved by the US Food and Drug Administration (FDA) for use in combination therapy for advanced breast cancer. Itovebi will be used alongside Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) and fulvestrant hormone therapy. This treatment is specifically for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer.

The FDA’s approval was based on the positive outcomes of the late-stage INAVO120 study. The study demonstrated that the combination therapy with Itovebi significantly reduced the risk of disease progression or death by 57% compared to the use of Ibrance and fulvestrant alone as a first-line treatment. Although overall survival data was not mature at the time of the primary analysis, there was a notable positive trend observed with the combination therapy. Roche has indicated that the overall survival data will continue to be monitored.

In the United States, an estimated 310,720 women are expected to be diagnosed with invasive breast cancer this year. HR-positive breast cancer is the most prevalent subtype of this disease. PIK3CA mutations, which are associated with tumor growth, disease progression, and treatment resistance, are present in roughly 40% of HR-positive metastatic breast cancers.

Roche has stated that Itovebi will be available in the US within the coming weeks. In addition, the results of the INAVO120 study are being submitted to other global health authorities, including the European Medicines Agency for further review.

Levi Garraway, Roche’s chief medical officer and head of global product development, expressed his enthusiasm for the approval, emphasizing the company's long-standing commitment to cancer therapeutic discovery. He noted that the approval of this Itovebi-based regimen provides an important new first-line option for patients with HR-positive breast cancer with a PIK3CA mutation. He highlighted the significance of the approval, given the limited treatment options available for this patient population despite the high prevalence of PIK3CA mutations.

This recent FDA approval follows closely on the heels of another significant regulatory milestone for Roche. Less than a month ago, the FDA approved Roche’s injectable monoclonal antibody Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of both relapsing and primary progressive multiple sclerosis. Additionally, the company has been granted breakthrough device designation by the US regulator for its Alzheimer’s disease blood test Elecsys pTau217, developed in collaboration with Eli Lilly.