# VEPPANU (vepdegestrant) PDUFA Event: ESR1-mutated, ER-positive, HER2-negative advanced or metastatic breast cancer

Canonical URL: https://biopharmsignal.com/pdufa-calendar/ARVN/veppanu-vepdegestrant-esr1-mutated-advanced-breast-cancer

Ticker: ARVN

Company: Arvinas, Inc.

Event date: 2026-06-05

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-05-01

Application type: NDA

FDA approved VEPPANU ahead of the PDUFA date. FDA approved vepdegestrant for adults with ESR1-mutated, ER-positive, HER2-negative advanced or metastatic brea...

## Event Timeline

### May 1, 2026 — FDA approved VEPPANU ahead of the PDUFA date

FDA approved vepdegestrant for adults with ESR1-mutated, ER-positive, HER2-negative advanced or metastatic breast cancer after progression on endocrine therapy. It became the first FDA-approved PROTAC protein degrader.

[Arvinas — VEPPANU FDA approval](https://ir.arvinas.com/news-releases/news-release-details/arvinas-announces-fda-approval-veppanu-vepdegestrant-treatment/)

### August 8, 2025 — FDA accepted the NDA

FDA accepted the application based on VERITAC-2 and assigned a June 5, 2026 PDUFA action date.

[Arvinas — Vepdegestrant NDA acceptance](https://ir.arvinas.com/news-releases/news-release-details/arvinas-announces-fda-acceptance-new-drug-application)

### June 6, 2025 — Arvinas and Pfizer submitted the NDA

The partners submitted the first NDA for a PROTAC therapy using the pivotal VERITAC-2 dataset.

[Arvinas — Vepdegestrant NDA submission](https://ir.arvinas.com/news-releases/news-release-details/arvinas-announces-submission-new-drug-application-us-fda)

### June 1, 2025 — VERITAC-2 results were presented and published

The Phase 3 results were presented at ASCO and simultaneously published in the New England Journal of Medicine, showing a progression-free survival benefit in the ESR1-mutated population versus fulvestrant.

[Arvinas — VERITAC-2 results supporting the NDA](https://ir.arvinas.com/news-releases/news-release-details/arvinas-announces-fda-acceptance-new-drug-application)

### March 3, 2023 — Phase 3 VERITAC-2 study started

The randomized pivotal study began comparing vepdegestrant with fulvestrant in previously treated ER-positive, HER2-negative advanced breast cancer.

[ClinicalTrials.gov — VERITAC-2 study record (NCT05654623)](https://clinicaltrials.gov/study/NCT05654623)

## Regulatory Designations

- Fast Track FDA: [Arvinas — Vepdegestrant NDA submission and Fast Track designation](https://ir.arvinas.com/news-releases/news-release-details/arvinas-announces-submission-new-drug-application-us-fda)

## Related Pages

- ARVN PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/ARVN.md

- ARVN company profile: https://biopharmsignal.com/company/ARVN.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

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- 2026-05-29 — Arvinas to Present at Jefferies Global Healthcare Conference: https://biopharmsignal.com/news/ARVN/arvinas-to-present-at-jefferies-global-healthcare-conference.md

- 2026-05-18 — Arvinas Employees Give Back During Company-wide Impact Day: https://biopharmsignal.com/news/ARVN/arvinas-employees-give-back-during-company-wide-impact-day.md

- 2026-05-12 — Arvinas Reports First Quarter 2026 Financial Results and Provides Corporate Update: https://biopharmsignal.com/news/ARVN/arvinas-reports-first-quarter-2026-financial-results-and-provides-corporate-update.md

- 2026-05-12 — Arvinas and Pfizer Enter into a Transaction with Rigel Pharmaceuticals for the Exclusive Global Rights of VEPPANU (vepdegestrant): https://biopharmsignal.com/news/ARVN/arvinas-and-pfizer-enter-into-a-transaction-with-rigel-pharmaceuticals-for-the-exclusive-global-rights-of-veppanu-vepdegestrant.md