FDA approves Roche’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

The FDA has approved Itovebi, in combination with palbociclib and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer. This approval is based on the results of the Phase III INAVO120 study, which demonstrated that the Itovebi-based regimen more than doubled progression-free survival compared to palbociclib and fulvestrant alone. The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers, and this approval addresses a significant unmet need for patients with this mutation. Itovebi is Roche's first targeted therapy approved for people with HR-positive disease, the most prevalent breast cancer subtype. The Itovebi-based regimen was granted FDA Priority Review and Breakthrough Therapy Designation based on the INAVO120 study results. Itovebi will be available in the US in the coming weeks. Early, comprehensive biomarker testing can help identify individuals with HR-positive, HER2-negative breast cancer with a PIK3CA mutation. Itovebi is currently being investigated in various combinations across three company-sponsored Phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer. This approval represents a significant step forward for patients with advanced breast cancer with a PIK3CA mutation.