FDA Approves New Targeted Treatment For Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With A PIK3CA Mutation
October 10th, 2024
On October 10, 2024, the FDA approved ItovebiTM (inavolisib) in combination with palbociclib and fulvestrant, a new first-line treatment option for people with HR+, HER2-, PIK3CA-mutated metastatic breast cancer, one of the most commonly mutated genes in metastatic breast cancer.
News in brief
- The Itovebi-based regimen offers a new, first-line treatment option for a patient population that has faced a poor prognosis and treatment challenges.
- The approval is based on the Phase III INAVO120 results showing the Itovebi-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting.
- PIK3CA mutations are found in approximately 40% of HR+ metastatic breast cancers, the most prevalent subtype.
- Despite the prevalence of PIK3CA mutations, many people are not tested until later in their treatment journey. Early, comprehensive biomarker testing prior to initiating first-line treatment can help identify people who may benefit from targeted therapy.
- Itovebi is Genentech’s first targeted therapy approved for people with HR+ breast cancer.
Supporting Information
“With the approval of this Itovebi-based regimen, we continue our long-standing track record of cancer therapeutic discovery by offering an important new first-line option for people living with HR-positive breast cancer with a PIK3CA mutation. Despite the high prevalence of PIK3CA mutations in this setting, treatment options have thus far remained limited, which makes today’s approval all the more significant.”