FDA Approves Roche’s Itovebi, a PI3K Inhibitor for Advanced Breast Cancer Treatment

FDA Approval:
The FDA has approved Roche's Itovebi (inavolisib), a PI3K inhibitor, in combination with palbociclib (Ibrance) and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.

Clinical Trial Results:
The approval is based on the Phase III INAVO120 study, which showed that the Itovebi-based regimen more than doubled progression-free survival compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months).

Significance:
This approval addresses an urgent unmet need in breast cancer for people with a PIK3CA mutation, which is found in approximately 40% of HR-positive metastatic breast cancers and is associated with poor prognosis.

Availability:
Itovebi will be available in the U.S. in the coming weeks and is also being investigated in various combinations across three company-sponsored Phase III clinical studies (INAVO120, INAVO121, INAVO122).

Market Impact:
The approval positions Itovebi as a potential challenger to Novartis’ PI3K inhibitor Piqray, which generated $505 million in revenue last year.