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

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

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2026Year5Month1Day,FDAApprovedArvinasAndPfizerJointly DevelopedPROTAC vepdegestrant(Product Name:VeppanuListing 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.
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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 received12Endocrine therapy (includingCDK4/6After the appearance of disease progression following the use of inhibitors).ESR1In mutation patients,VeppanuSignificantly improvedPatientProgression-Free Survival. MedianPFSFor5.0Months (95% CI3.7–7.4)。pPFSDid not achieve significant prolongation,mPF is3.7Months,HR=0.83p=0.0358OSData 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)。
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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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