Shots:
- FDA approved Veppanuto treat adults with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer who received ≥1L of endocrine therapy, prior to PDUFA date of Jun 5, 2026; Arvinas & Pfizer plan to select a third-party partner for commercialization
- NDA was backed by P-III (VERITAC-2) trial assessing Veppanu alone vs fulvestrant in mentioned pts (n=624: 270 were ESR1m positive) previously treated with CDK4/6 inhibitor + endocrine therapy
- Trial showed improved PFS (1EP) by 43% in ESR1-mutated pts (n=270), with mPFS of 5 vs 2.1mos. OS data was immature with 16% of deaths in this group at PFS analysis
Ref: Globenewswire | Image: Arvinas |Press Release
Related News: Arvinas Reports the US FDA’s NDA Acceptance of Vepdegestrant for ESR1-Mutated Breast Cancer
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