Pfizer, Arvinas Win FDA Nod for PROTAC Therapy Cutting Progression Risk 43%
PFE•Pfizer and Arvinas won FDA approval for VEPPANU, the first PROTAC therapy for advanced ESR1-mutated breast cancer. Phase 3 VERITAC-2 data showed VEPPANU reduced disease progression risk by 43% versus fulvestrant, extending median PFS to 5 months from 2.1, and Guardant360 CDx gained companion diagnostic approval.
1. FDA Approval Overview
The FDA has approved VEPPANU (vepdegestrant), the first PROTAC-based therapy for women with advanced breast cancer harboring ESR1 mutations, marking a novel modality in targeted oncology treatment.
2. Phase 3 VERITAC-2 Trial Data
In the Phase 3 VERITAC-2 trial, VEPPANU achieved a 43% reduction in risk of disease progression compared to fulvestrant, with patients showing a median progression-free survival of 5.0 months versus 2.1 months.
3. Companion Diagnostic Approval
Guardant Health’s Guardant360 CDx assay received approval as a companion diagnostic to identify ESR1-mutated patients eligible for VEPPANU therapy, facilitating personalized treatment selection.
4. Market and Financial Implications
This approval could bolster Pfizer’s oncology revenues as VEPPANU addresses a high unmet need segment, with analysts forecasting peak annual sales in the multibillion-dollar range ahead of major patent expirations.
