New Drug Application- Vepdegestrant

Arvinas, Inc. announced the submission of a New Drug Application (NDA) to the USFDA with its partner Pfizer Inc., for vepdegestrant for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. 

This submission is based on results from VERITAC-2 (NCT05654623), a global, randomised Phase 3 trial evaluating vepdegestrant versus fulvestrant.


Certain bifunctional compounds can target specific cellular proteins for degradation via the ubiquitin-proteasome system. Examples of such proteolysis-targeting chimeric compounds (i.e., “PROTAC® protein degraders”) that target the Estrogen Receptor (ER) for ubiquitination and subsequent degradation are disclosed in patent family WO 2018102725 filed by Arvinas. 


Patent family WO2024049922 A1 (Arvinas) describes Vepdegestrant for use in treating cancer. Patent family WO2025038481 A1 relates to the Vepdegestrant dosage regimen in CYP3A-inducer treatment for cancer.



The most probable structure of vepdegestrant would be




It is estimated that, as of January 2017, approximately 155,000 women with metastatic breast cancer (mBC) were living in the U.S. It was also reported that the number of women living with mBC is increasing, primarily due to improvements in treatment and the aging of the U.S. population. The estimated number of women living with mBC increased by 17% from 2000 to 2010 and is projected to rise by 31% from 2010 to 2020 (Mariotto A. B. et al. ‘Estimation of the Number of Women Living with Metastatic Breast Cancer in the United States” Cancer Epidemiol. Biomarkers Prev. 2017, 26(6):809-815.).


Vepdegestrant, a PROTAC ER degrader, is expected to generate peak sales of around $576 million, according to Leerink Partners. Another source predicts peak global sales of $2.9 billion in the specific patient population, according to Reuters.




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