11-08-2025
FDA gives Arvinas and Pfizer's vepdegestrant NDA for breast cancer
Arvinas, in collaboration with Pfizer, has announced new drug application (NDA) acceptance for vepdegestrant from the US Food and Drug Administration (FDA) to treat breast cancer.
The treatment is aimed at patients with oestrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), oestrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer who have previously undergone endocrine-based therapy.
The Prescription Drug User Fee Act (PDUFA) action date is set for 5 June 2026.
Vepdegestrant is an investigational, oral bioavailable PROteolysis TArgeting Chimera (PROTAC) medication designed to degrade oestrogen receptors.
It is being developed collaboratively by Arvinas and Pfizer as a potential monotherapy option.
The submission was based on results from VERITAC-2, a randomised, global Phase III study that compared vepdegestrant against fulvestrant.
Patients were randomly assigned in a 1:1 ratio to receive either vepdegestrant, administered orally once daily on a continuous 28-day schedule, or fulvestrant, which was given intramuscularly. 43% of the patients in the trial had detectable ESR1 mutations.
Progression-free survival (PFS), measured both in patients with ESR1 mutations and across all trial participants, served as the primary endpoint evaluated through blinded independent central review.
Overall survival (OS) remains an important secondary endpoint.
Arvinas chairperson, CEO and president John Houston stated: 'Patients often face limited treatment options after first-line treatment and vepdegestrant demonstrated improved progression-free survival in patients with ESR1-mutated ER+/HER2- advanced breast cancer.
'With the efficacy and favourable tolerability seen in VERITAC-2, we believe vepdegestrant, if approved, has potential to be a best-in-class treatment option for patients in the second-line ESR1-mutant setting.'
In August 2025, Pfizer raised its full-year profit forecast, driven by robust sales of its heart disease medication Vyndaqel (tafamidis) and the blood thinner Eliquis (apixaban), among other products.
"FDA gives Arvinas and Pfizer's vepdegestrant NDA for breast cancer" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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