FDA Approves Veppanu (Vepdegestrant), the First-in-Class Oral PROTAC for ESR1-Mutated Advanced Breast Cancer

May 02, 2026 21:03 CST Updated 21:03

Arvinas

Developer of drugs in the fields of oncology and neurodegenerative diseases

Pfizer

Pharmaceutical R&D Developer

2026Year5Month1Day,FDAApprovedArvinasAndPfizerJointly DevelopedPROTAC vepdegestrant(Product Name:Veppanu）Listing Application, used forESR1Adults with mutations who have experienced disease progression after receiving at least one line of prior endocrine therapy.ERPositive,HER2Patients with negative advanced or metastatic breast cancer.

This approval is based onIIIPeriodVERITAC-2Trial (NCT05654623) Result.The study enrolled a total of624ExampleERPositive,HER2Patients with negative advanced or metastatic breast cancer, wherein270Example withESR1Mutation. The patient has previously received1～2Endocrine therapy (includingCDK4/6After the appearance of disease progression following the use of inhibitors).ESR1In mutation patients,VeppanuSignificantly improvedPatientProgression-Free Survival. MedianPFSFor5.0Months (95% CI，3.7–7.4）。pPFSDid not achieve significant prolongation,mPF is3.7Months,HR=0.83，p=0.0358。OSData are not yet mature. In terms of safety,3Grade and above side effects are mainly fatigue (26.6% vs 17.6%Fulvestrant），ALTIncrease (14.4% vs 9.8%）、ASTIncrease (14.4% vs 10.4%), Nausea (13.5% vs 8.8%), the proportion of treatment discontinuation due to side effects was2.9%（0.7%Fulvestrant）。

References:

ArvinasOfficial Website

Campone M, De Laurentiis M, Jhaveri K, et al. Vepdegestrant, a PROTAC Estrogen Receptor Degrader, in Advanced Breast Cancer. N Engl J Med.

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