FDA approves Vepdegestrant (Veppanu) for ESR1-mutated breast cancer
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The FDA approved vepdegestrant (Veppanu) on May 1, 2026 for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after endocrine therapy. For BD teams and investors, the key read-through is a new catalyst tied to an FDA-labeled oral protein degrader and a clearly defined biomarker-selected population.
The Vepdegestrant FDA approval covers VEPPANU for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one endocrine therapy line. DailyMed labeling and VERITAC-2 (NCT05654623) set the labeled dose, biomarker gate, and progression-free survival benchmark versus fulvestrant.
Contents9 sections
Key Takeaways
- VEPPANU (vepdegestrant) is labeled for ER+/HER2−, ESR1-mutated advanced or metastatic breast cancer after ≥1 endocrine line, with FDA-authorized testing required.
- Recommended dose is 200 mg orally once daily with food (100 mg and 200 mg tablets).
- In VERITAC-2 ESR1-mutated patients, median BICR PFS was 5.0 vs 2.1 months (HR 0.57); ORR 19% vs 4% versus fulvestrant.
- Overall survival was immature (16% deaths) at the PFS analysis; combination and special-population trials remain listed on ClinicalTrials.gov.
What does the Vepdegestrant FDA approval cover?
Per DailyMed prescribing information for VEPPANU, the drug is a heterobifunctional protein degrader for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer detected by an FDA-authorized test, after disease progression following at least one line of endocrine therapy. Initial U.S. approval is listed as 2026.
Patient selection uses ESR1 mutation(s) in a plasma specimen with an FDA-authorized test. That biomarker gate defines the commercial and trial population more tightly than a broad ER+/HER2− label.
How strong was the VERITAC-2 evidence?
VERITAC-2 (NCT05654623) enrolled 624 adults with ER+/HER2− advanced or metastatic breast cancer; 270 had ESR1-mutated tumors. Patients needed progression on one to two prior endocrine lines, including one with a CDK4/6 inhibitor.
- Randomization was 1:1 to VEPPANU 200 mg orally once daily (N=313) or fulvestrant 500 mg intramuscularly (N=311).
- In the ESR1-mutated efficacy set (VEPPANU N=136; fulvestrant N=134), median BICR PFS was 5.0 months (95% CI 3.7–7.4) versus 2.1 months (95% CI 1.9–3.5).
- Hazard ratio was 0.57 (95% CI 0.42–0.77); one-sided p-value 0.0001.
- Confirmed ORR was 19% (95% CI 12–27) versus 4% (95% CI 1.6–10); complete responses were 0% in both arms.
- Overall survival was immature, with 16% of deaths at the PFS analysis.
Those figures come from the Clinical Studies section of the VEPPANU DailyMed label, not from secondary news summaries.
Dosing, formulation, and safety watch-outs
Labeled dosing is 200 mg once daily with food until progression or unacceptable toxicity. Tablets are supplied as 100 mg and 200 mg strengths (NDC 71332-007-30 and 71332-008-30). Strong CYP3A inhibitors and inducers require dose adjustments described in the label.
In VERITAC-2, QTc prolongation was reported in 10% of VEPPANU-treated patients (Grade 3 in 1.6%). Among patients who received VEPPANU, 33% were exposed for six months or longer and 6% for more than one year. Full adverse-reaction tables remain the prescribing-information source of truth.
Sponsor context and commercialization notes
Arvinas Operations, Inc. is the labeled applicant. Arvinas’s May 1, 2026 GlobeNewswire release stated FDA approval of VEPPANU for the ESR1-mutated ER+/HER2− advanced breast cancer population and described the asset as the first FDA-approved PROTAC-type heterobifunctional degrader. The same wire notes the Arvinas–Pfizer collaboration framework; commercial execution details beyond that statement are outside the label.
What remains unproven after approval
Overall survival benefit is not established in the immature VERITAC-2 OS analysis. The label does not by itself prove superiority versus every post-CDK4/6 oral endocrine option outside the fulvestrant-controlled design. Combination strategies and hepatic-impairment pharmacokinetics are still being studied in listed trials such as NCT06125522 and NCT07231991 on ClinicalTrials.gov.
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Frequently Asked Questions
What is the Vepdegestrant FDA approval indication?
VEPPANU (vepdegestrant) is indicated for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, detected by an FDA-authorized test, after progression on at least one line of endocrine therapy.
What VERITAC-2 results support Veppanu?
In ESR1-mutated patients in VERITAC-2 (NCT05654623), median BICR-assessed PFS was 5.0 months with VEPPANU versus 2.1 months with fulvestrant (hazard ratio 0.57; 95% CI 0.42–0.77). Confirmed ORR was 19% versus 4%.
What is the recommended Veppanu dose?
The recommended dosage is 200 mg taken orally once daily with food until disease progression or unacceptable toxicity, per the U.S. prescribing information.
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