Roche announced that the US Food and Drug Administration (FDA) has approved Itovebi (inavolisib) combination therapy to treat adults with an advanced breast cancer condition.
Itovebi is now approved in combination with palbociclib (Ibrance) and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer.
This treatment is for patients whose cancer has recurred after adjuvant endocrine therapy.
The FDA approval is based on the Phase 3 randomised, double-blind, placebo-controlled INAVO120 study, which enrolled 325 patients.
It showed a statistically significant and clinically meaningful benefit when using the Itovebi regimen.
According to the results, the Itovebi combination reduced the risk of disease progression or death by 57% compared to palbociclib and fulvestrant alone.
Patients treated with inavolisib had a median progression-free survival of 15 months, compared to 7.3 months for the control group.
While overall survival (OS) data are still immature, during the primary analysis, a positive trend was noted. Follow-up for OS continues for further analysis.
Roche chief medical officer and global product development head Levi Garraway said: “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.”
The Itovebi-based regimen received FDA priority review and breakthrough therapy designation in May 2024, based on INAVO120 study results.
Data from this study will also support submissions to global health authorities, including the European Medicines Agency.
Inavolisib is expected to be available in the US in the coming weeks.
Additionally, the FDA has approved Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic tool to identify eligible patients for Itovebi. Roche is the parent company of Foundation Medicine.
Inavolisib is also being studied in the INAVO120, INAVO121, and INAVO122 Phase 3 trials for PIK3CA-mutated, locally advanced or metastatic breast cancer.
