FDA record · Cancer
What FDA's own documents say about Veppanu: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
“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.”
Prescribing information, original approval · PDF p. 1 · fda.gov ↗
| Trial | ClinicalTrials.gov | Phase | Mentions | Documents |
|---|---|---|---|---|
| VERITAC-2C4891001 | NCT05654623 | 3 | 128 | 8 of 11 |
| CPhm-103 | not given | 5 | 1 of 11 | |
| ARV-471ARV-471-mBC-101 | NCT04072952 | 1/2 | 1 | 1 of 11 |
Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.
Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.
PFS
“There was a statistically significant and clinically meaningful improvement in PFS by BICR in the vepdegestrant arm when compared with the fulvestrant arm in participants with ESR1 mutations (stratified HR = 0.57 [95% CI: 0.418, 0.770], 1-sided p-value = 0.0001).”
Multi-disciplinary Review · PDF p. 97 · fda.gov ↗
95%p-value = 0.0001
PFS
“PFS was not met in the "All Participants" population (HR 0.83 [95% CI: 0.676, 1.016, 1-sided p=0.0358]).”
Administrative Correspondence · PDF p. 6 · fda.gov ↗
95%p=0.0358
“Recommended Dosage: 200 mg orally once daily with food.”
Prescribing information, original approval · PDF p. 1 · fda.gov ↗
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Approval letter219835Orig1s000ltr.pdf | May 4, 2026 | 5 | 0ee8d0e2f0de | |
| Administrative Correspondence219835Orig1s000AdminCorres.pdf | May 27, 2026 | 52 | e1ebe560c202 | |
| Approval Letter219835Orig1s000Approv.pdf | May 27, 2026 | 10 | 213f11e5df19 | |
| Chemistry Review219835Orig1s000ChemR.pdf | May 27, 2026 | 66 | 233751ad5559 | |
| Prescribing Information (Label)219835Orig1s000Lbl.pdf | May 27, 2026 | 22 | f75713b2a8e9 | |
| Multi-disciplinary Review219835Orig1s000MultidisciplineR.pdf | May 27, 2026 | 298 | f4f75ab78ced | |
| Proprietary Name Review219835Orig1s000NameR.pdf | May 27, 2026 | 19 | 6cee7d50226f | |
| Officer/Employee List219835Orig1s000OEList.pdf | May 27, 2026 | 2 | 60fb4807b0dc | |
| Other Reviews219835Orig1s000OtherR.pdf | May 27, 2026 | 60 | b89c2a6b1c2a | |
| Risk Assessment / REMS Review219835Orig1s000RiskR.pdf | May 27, 2026 | 14 | 3a7d210d4819 | |
| Prescribing information, original approval219835Orig1s000lbl.pdf | June 1, 2026 | 18 | 882bd50afd16 |
Checked against FDA's copies on September 30, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.
Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.