FDA Approves Itovebi for Treatment of PIK3CA-Mutated Breast Cancer

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Emedinexus 24 June 2025

The U.S. Food and Drug Administration (FDA) has granted approval for Itovebi to treat breast cancer patients with PIK3CA mutations. This milestone decision is grounded in the results of the Phase 3 INAVO120 study, which demonstrated a statistically significant and clinically meaningful benefit of the Itovebi regimen.

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