Brand Name
Veppanu
Generic Name
Vepdegestrant
View Brand Information FDA approval date: May 01, 2025
Form: Tablet
What is Veppanu (Vepdegestrant)?
VEPPANU is indicated for the treatment of adults with estrogen receptor -positive, human epidermal growth factor receptor 2 -negative, estrogen receptor-1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. VEPPANU is a heterobifunctional protein degrader indicated for the treatment of adults with estrogen receptor -positive, human epidermal growth factor receptor 2 -negative, estrogen receptor-1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
Approved To Treat
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Brand Information
VEPPANU (vepdegestrant)
1INDICATIONS AND USAGE
VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative,
2DOSAGE FORMS AND STRENGTHS
Tablets:
- 100 mg blue film-coated, immediate release, round tablet debossed with "VEP" on one side and "100" on the other side.
- 200 mg blue film-coated, immediate release, oval tablet debossed with "VEP" on one side and "200" on the other side.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reaction is described elsewhere in the labeling:
- QTc Interval Prolongation
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of VEPPANU was evaluated in patients with ER-positive, HER2-negative, advanced or metastatic breast cancer following endocrine therapy in VERITAC-2
Patients received VEPPANU 200 mg orally once daily (N=312) or fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28-day cycle (N=307). Among patients who received VEPPANU, 33% were exposed for 6 months or longer and 6% were exposed for greater than one year.
Serious adverse reactions occurred in 9% of patients who received VEPPANU. The serious adverse reactions included any fracture (1.3%), fall, hypercalcemia, hepatic injury, pneumonia, musculoskeletal pain (0.6% each), and QTc prolonged (0.3%). Fatal adverse reactions occurred in 1.0% of patients who received VEPPANU, including dyspnea, cerebral ischemia, and unknown cause (one patient each).
Permanent discontinuation of VEPPANU due to an adverse reaction occurred in 2.9% of patients. Adverse reactions that resulted in permanent discontinuation of VEPPANU included increased alanine aminotransferase (ALT) and dyspnea (0.6% each).
Dosage interruptions of VEPPANU due to an adverse reaction occurred in 14% of patients. Adverse reactions which required dosage interruption in >1% of patients included neutropenia (1.9%), anemia, hepatic injury, nausea, fatigue, and musculoskeletal pain (1.3% each).
Dosage reductions of VEPPANU due to an adverse reaction occurred in 1.9% of patients. Adverse reactions which required dosage reductions of VEPPANU included electrocardiogram QT prolonged, fatigue and musculoskeletal pain (0.3% each).
The most common (≥10%) adverse reactions, 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.
Table 3 and Table 4 summarize adverse reactions and laboratory abnormalities in VERITAC-2, respectively.
Clinically relevant adverse reactions in <10% of patients who received VEPPANU included headache, hot flush, diarrhea, vomiting, bradycardia, and urinary tract infection.
5DESCRIPTION
Vepdegestrant is a heterobifunctional protein degrader. It is a small molecule comprised of an estrogen receptor binding domain joined by a linker to an E3 ligase binding domain. The chemical name of vepdegestrant is 2,6-piperidinedione, 3-[1,3-dihydro-1-oxo-5-[4-[[1-[4-[(1
Vepdegestrant is white to off-white to pale yellow solid with the molecular formula of C
VEPPANU is supplied as blue film-coated, immediate release tablets containing either 100 mg or 200 mg vepdegestrant together with: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate, vitamin E-polyethylene glycol succinate, and Opadry
6CLINICAL STUDIES
The efficacy of VEPPANU was evaluated in VERITAC-2 (NCT05654623), a randomized, open-label, active-controlled, multicenter trial that enrolled 624 adult patients with ER-positive, HER2-negative, advanced or metastatic breast cancer, of whom 270 patients had tumors carrying
Patients were randomized 1:1 to receive VEPPANU 200 mg orally once daily (N=313), or fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and then once monthly thereafter (N=311). Randomization was stratified by ESR1 mutation status (detected vs. not detected) and visceral metastasis (yes vs. no).
Among the patients whose tumors had
The major efficacy outcome was progression-free survival (PFS) as assessed by blinded independent central review (BICR) in the population of patients whose tumors had an
A statistically significant difference in PFS by BICR was observed for the patients whose tumors had
Overall survival was immature with 16% of deaths in this population at the time of the PFS analysis. Efficacy results are provided in
Figure 1: Kaplan-Meier Plot of Progression-Free Survival Based on BICR Assessment in VERITAC-2 (Patients with ESR1-Mutated Tumors)
7HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
VEPPANU (vepdegestrant) film-coated tablets for oral use are supplied in bottles of 30 tablets with child-resistant closures as follows:
Storage
Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C (between 59°F and 86°F) [see USP controlled room temperature].
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
QTc Interval Prolongation
Inform patients that VEPPANU can cause QTc interval prolongation, which may increase the risk of Torsade de Pointes, other ventricular arrhythmias, and sudden death. Advise patients or caregivers of the signs or symptoms associated with the clinical consequences of QTc interval prolongation and to seek immediate medical attention if these are suspected or develop. Instruct patients to consult with their healthcare provider prior to taking other drugs that cause QTc interval prolongation with VEPPANU
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy
Advise females of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose
Lactation
Advise women not to breastfeed during treatment with VEPPANU and for 2 weeks after the last dose
Infertility
Advise males and females of reproductive potential that VEPPANU may impair fertility
Drug Interactions
Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products. Inform patients to avoid St. John's wort, grapefruit, or grapefruit juice while taking VEPPANU
Administration
Advise patients to take VEPPANU with food, how to make up for a missed or vomited dose, and to swallow tablet(s) whole without chewing, crushing, dissolving or splitting the tablet
Manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany 79108
Manufactured for Rigel Pharmaceuticals, Inc., South San Francisco, CA 94080
VEPPANU is a trademark of Rigel Pharmaceuticals, Inc.
For more information go to www.VEPPANU.com or call 1-800-983-1329
06/2026
9PRINCIPAL DISPLAY PANEL - 100 mg Tablets Bottle Label
NDC 71332-007-30
VEPPANU™
(vepdegestrant)
tablets
100 mg
rigel
30 Tablets
Rx only
10PRINCIPAL DISPLAY PANEL - 200 mg Tablets Bottle Label
NDC 71332-008-30
VEPPANU™
(vepdegestrant)
tablets
200 mg
rigel
30 Tablets
Rx only
