FDA Approves Genentech's Itovebi For Advanced Breast Cancer With PIK3CA Mutation

(RTTNews) - Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration approved Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers.

The company noted that the approval is based on results of the pivotal Phase III INAVO120 study, which showed that the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the first-line setting, demonstrating a statistically significant and clinically meaningful benefit.

Itovebi will be available in the U.S. in the coming weeks.

Itovebi is currently being investigated in various combinations across three company-sponsored Phase III clinical studies (INAVO120, INAVO121, INAVO122) in PIK3CA-mutated locally advanced or metastatic breast cancer.

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