Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to vepdegestrant for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

This is written in the approval document as:

VEPPANU is a heterobifunctional protein degrader indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

Citation

Rigel Pharms. Veppanu (vepdegestrant) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219835Orig1s000lbl.pdf. Revised May 2026. Accessed October 8, 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, ESR1 activating variants, HER2-negative	Invasive Breast Carcinoma	Vepdegestrant

Contributions

Date	Contributor	Description
2026-10-08	Van Allen lab	Initial curation of this indication into moalmanac-db.
2026-05-01	Food and Drug Administration	Indication received traditional approval.