Roche has received approval for Itovebi in combination with palbociclib and fulvestrant to treat breast cancer.
The therapeutic combination is cleared for use in patients with PIK3CA-mutated, HR+ HER2- breat cancer that has locally advanced or is showing signs for metastasis.
This approval stems from the results of the Phase III INAVO120 trial, which indicated that the Itovebi-based regimen can reduce risk of disease progression or death by up to 57% compared with palbociclib and fulvestrant alone.
A follow-up of the overall survival (OS) rate statistics wil also be provided further down the line.
Roche's Itovebi-based treatment regimen was granted FDA Priority Review and Breakthrough Therapy Designation in May 2024 following the INAVO120 study results.
Itovebi will be available in the US in a few weeks, according to Roche.
Komal Jhaveri, one of the principal investigators of the INAVO120 study, commented: “The Itovebi-based regimen more than doubled progression-free survival and maintained a manageable safety and tolerability profile, adding a new standard in how PIK3CA-mutated breast cancers are treated."
Roche's Chief Medical Officer and Head of Global Product Development, Levi Garraway, added: "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.”
Itovebi's efficacy is currently being assessed in a range of contexts across three Phase III clinical studies, inclduing INAVO120, INAVO121 and INAVO122.