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# Arvinas Files NDA for Breast Cancer Drug
- URL: https://www.fdaweb.com/arvinas-files-nda-for-breast-cancer-drug/
- Published: 2025-06-06T12:00:00.000Z
- Updated: 2026-09-14T15:13:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159319

Arvinas has submitted an NDA for vepdegestrant for treating patients with estrogen receptor-positive human epidermal growth factor receptor 2-negative ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy.

The submission is based on results from VERITAC-2 (NCT05654623), a Phase 3 trial evaluating vepdegestrant versus fulvestrant. The primary endpoint was progression-free survival in the ESR1-mutation and intent-to-treat populations as determined by a blinded independent central review, the company says, adding that overall survival is the key secondary endpoint. Results from the VERITAC-2 study were recently presently at the [American Society of Clinical Oncology](https://www.globenewswire.com/Tracker?data=RPbgnF0Ge393Y4DU1aktW4V%5FTvvfTaJjRWaxxiEjiSggE9E9o0j7PoFRr09pWGFhTk2JBigbRN%5FMLY%5FxBga3zhanJOJj5aepLjs0mYNv9WvOu2Mc0a5fligdzQiiRXxZAuP1D56jNnbhxjS1x0aMVIq5KsX4i0F2Bpz5sCHlz%5FsKMN%5FD4xqfwpr3BgcIJAXe%5FEOvC5sDJaKX77wD6d0hUpNt%5F0U0X-V9Bob0xRWxTnWnxLUz166mML1MAijKM3xSqGO-TV-ozJYo7BjOnpHfBhE8LTJfo%5FlauqCNdYDg48UQ7NXLK95PDyyrySlXJ9tU&ref=fdaweb.com) 2025 annual meeting.

Vepdegestrant is described as an investigational, orally bioavailable PROTAC (PROteolysis TArgeting Chimera) protein degrader designed to specifically target and degrade the estrogen receptor. It is being developed under a global collaboration.