FDA accepts Arvinas NDA for vepdegestrant in ER+/HER2- advanced breast cancer; PDUFA June 2026

ARVINAS, INC.

NDA based on Phase 3 VERITAC-2 trial showing statistically significant PFS improvement vs fulvestrant.
Vepdegestrant is the first PROTAC to demonstrate clinical benefit in breast cancer.
FDA assigned PDUFA action date of June 5, 2026.
Jointly developed with Pfizer (NYSE: PFE).
Target patient population: second-line ESR1-mutant ER+/HER2- advanced/metastatic breast cancer.

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