Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that ER positive, ESR1 activating variants, and HER2-negative status confers therapeutic sensitivity to Vepdegestrant in patients with Invasive Breast Carcinoma.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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. 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.

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.