Arvinas announces FDA acceptance of the new drug application for vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer

Arvinas

8 August 2025 - Filing based on pivotal Phase 3 VERITAC-2 clinical trial demonstrating statistically significant and clinically meaningful improvement in median progression-free survival versus fulvestrant.

Arvinas today with its partner Pfizer announced that the US FDA has accepted the new drug application for vepdegestrant for the treatment of patients with estrogen receptor positive/human epidermal growth factor receptor 2-negative, ESR1 mutated advanced or metastatic breast cancer who have previously received endocrine-based therapy.

Read Arvinas press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier