# FDA Sets June 5, 2026 PDUFA Date for Vepdegestrant in ESR1-Mutated Breast Cancer

> fda · REPORTED · 2026-06-05

The FDA assigned a PDUFA action date of June 5, 2026 for vepdegestrant, Arvinas and Pfizer's investigational proteolysis-targeting chimera (PROTAC) degrader, for ESR1-mutated, ER-positive/HER2-negative advanced breast cancer following the accepted NDA. This represents a potentially first-in-class mechanism for endocrine-resistant metastatic breast cancer.

About Pfizer / Arvinas: Arvinas (partnered with Pfizer) is a clinical-stage biopharmaceutical company developing PROTAC protein degraders targeting the estrogen receptor for patients with treatment-resistant hormone receptor-positive breast cancer.

- Company: Pfizer / Arvinas
- Sector: oncology
- Primary source: https://www.onclive.com/view/fda-flashback-breast-cancer-decisions-and-news-from-march-2026

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.