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FDA Approves Roche’s Itovebi for Breast Cancer

Approval is based on the results of the pivotal Phase III INAVO120 study.

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By: Charlie Sternberg

Associate Editor

The United States Food and Drug Administration (FDA) has approved Roche’s 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 ...

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