On 8 August 2025 FDA has accepted a New Drug Application (NDA) for Vepdegestrant for the treatment of ESR1-mutated ER+/HER2-advanced breast cancer patients based on the pivotal Phase 3 VERITAC-2 clinical trial (NCT05654623), demonstrating statistically significant and clinically meaningful improvement in median progression-free survival (PFS) compared to Fulvestrant [6,7]. Here, ESR1 is linked to breast cancer.