Roche Gains FDA Approval for Itovebi in Advanced HR-Positive, HER2-Negative Breast Cancer with PIK3CA Mutation
Friday, October 11, 2024
Roche announced that the United States Food and Drug Administration (FDA) has approved Itovebi™ (inavolisib) for use in combination with palbociclib (Ibrance®) and fulvestrant.
HR-positive breast cancer, which accounts for about 70% of all breast cancer cases, often faces challenges related to disease progression. The PIK3CA mutation is recognised as a contributor to resistance against standard endocrine therapies, highlighting the need for innovative treatment approaches like the Itovebi-based regimen.
This new treatment is aimed at adults with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence after adjuvant endocrine therapy.
The PIK3CA mutation, present in around 40% of HR-positive metastatic breast cancers, plays a significant role in disease progression.
The FDA’s approval is based on data from the pivotal Phase III INAVO120 study. The results demonstrated that the Itovebi-based regimen significantly reduced the risk of disease progression or death by 57%, compared to palbociclib and fulvestrant alone (15.0 months versus 7.3 months).
Though overall survival data is still maturing, a clear positive trend was noted. Itovebi has also been granted FDA Priority Review and Breakthrough Therapy Designation earlier this year.
With the approval, Itovebi will offer a new first-line treatment option for patients with PIK3CA-mutated breast cancer in the US.
Roche is also pursuing regulatory submissions to other global health authorities, including the European Medicines Agency.
Biomarker testing, such as FoundationOne®Liquid CDx, is essential to identify patients who may benefit from this therapy.
Itovebi is currently being evaluated in three ongoing Phase III clinical trials to further expand its use in breast cancer treatment, including the INAVO121 and INAVO122 studies.
Source: roche.com
