Initial US Approval:
2026
Key Clinical Studies:
VERITAC-2 (NCT05654623)
Drug Class/Description:
Heterobifunctional protein degrader
Indications and Usage:
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.
Dosage and Administration:
- Select patients for treatment with VEPPANU based on the presence of ESR1 mutation.
- Recommended Dosage: 200 mg orally once daily with food.
- Interruption, dose reduction, or permanent discontinuation may be required due to adverse reactions.
Dosage Forms and Strengths:
Tablets: 100 mg and 200 mg
Contraindications:
None.
Warnings and Precautions:
- QTc Interval Prolongation: Monitor electrocardiograms (ECGs) and electrolytes prior to initiation of treatment with VEPPANU. Correct hypokalemia and hypomagnesemia prior to and during treatment. Repeat ECGs as clinically indicated. Withhold, reduce dose, or permanently discontinue VEPPANU based on severity.
- Embryo-Fetal Toxicity: VEPPANU can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Adverse Reactions:
Most common (≥10%) adverse reactions with VEPPANU, including laboratory abnormalities, were decreased white blood cells, increased AST, musculoskeletal pain, fatigue, decreased hemoglobin, decreased neutrophils, increased ALT, increased alkaline phosphatase, nausea, decreased blood potassium, increased bilirubin, decreased appetite, electrocardiogram QT prolonged, decreased platelets, and constipation.
Drug Interactions:
- Strong CYP3A Inhibitors: Avoid concomitant use with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce VEPPANU dosage.
- Strong CYP3A Inducers: Avoid concomitant use with strong CYP3A inducers. If concomitant use cannot be avoided, increase VEPPANU dosage.
- Certain P-gp Substrates: Avoid concomitant use with certain P-gp substrates where minimal increases in concentration may lead to serious adverse reactions.
- Certain UGT1A9 Substrates: Refer to the Prescribing Information for UGT1A9 substrates where minimal increases in concentration may lead to serious adverse reactions.
Use in Specific Populations:
- Lactation: Advise not to breastfeed.
Adapted From:
https://www.arvinas.com/wp-content/uploads/2026/05/NDA-219835_Approval-Rx-ONLY.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
