FDA Approves Arvinas and Pfizer's Veppanu (vepdegestrant), First PROTAC for ESR1-Mutated Breast Cancer

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The FDA approved Veppanu (vepdegestrant) on May 1, 2026, for adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer after at least one line of endocrine therapy.13

Veppanu is the first FDA-approved PROTAC, a heterobifunctional protein degrader that targets estrogen receptors for degradation.123

Approval came ahead of the PDUFA date of June 5, 2026.14

In the VERITAC-2 trial, vepdegestrant reduced progression-free survival risk by 43% vs. fulvestrant in ESR1-mutated patients.13

Developed by Arvinas and Pfizer; Guardant360 CDx approved as companion diagnostic.13

Addresses unmet need in treatment-resistant ESR1-mutated breast cancer.12

Sources:

1. https://ir.arvinas.com/news-releases/news-release-details/arvinas-announces-fda-approval-veppanu-vepdegestrant-treatment

2. https://www.biopharmadive.com/news/arvinas-pfizer-fda-approve-veppanu-vepdegestrant-breast-cancer/819108/

3. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vepdegestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast

4. https://www.morningstar.com/news/dow-jones/202605015765/arvinas-pfizer-get-fda-approval-for-breast-cancer-treatment