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# NDA Filed for PROTAC Therapy in Breast Cancer
- URL: https://www.fdaweb.com/nda-filed-for-protac-therapy-in-breast-cancer/
- Published: 2025-08-11T12:00:00.000Z
- Updated: 2026-09-14T15:18:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159660

FDA has accepted for review an Arvinas and Pfizer NDA for vepdegestrant, a first-in-class oral PROteolysis TArgeting Chimera (PROTAC) therapy for treating estrogen receptor–positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer in patients who have previously received endocrine-based therapy. The agency has set a user fee review action target date of 6/5/2026.

Arvinas says vepdegestrant is the first PROTAC to demonstrate a clinical benefit in breast cancer. The submission is based on data from the Phase 3 VERITAC-2 trial, which showed that the drug delivered a statistically significant and clinically meaningful improvement in median progression-free survival compared with fulvestrant, a current standard treatment, it says.