Arvinas submits NDA to FDA for vepdegestrant in ER+/HER2- ESR1-mutated breast cancer

ARVINAS, INC.

NDA supported by pivotal Phase 3 VERITAC-2 trial results presented at ASCO 2025 and published in NEJM.
Vepdegestrant is a first-in-class PROTAC ER degrader; fast track designation granted by FDA.
If approved, vepdegestrant would be first FDA-approved PROTAC ER degrader for advanced breast cancer.
Jointly developed with Pfizer (PFE); NDA covers ER+/HER2- ESR1-mutated advanced/metastatic breast cancer.
VERITAC-2 enrolled 624 patients across 25 countries; primary endpoint PFS in ESR1-mutation and ITT populations.

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