Breast Cancer Treatments/Medical Treatments

FDA Approves New Oral Treatment for Some Advanced Breast Cancers

Written by Ted Samson

Posted on June 3, 2026

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The U.S. Food and Drug Administration (FDA) has approved vepdegestrant (Veppanu) for adults with estrogen receptor-positive (ER-positive), HER2-negative, ESR1-mutated advanced or metastatic breast cancer. The approval is for people whose cancer has gotten worse after trying at least one line of endocrine-based therapy, and who have the ESR1 mutation (genetic change).

This drug approval matters because some ER-positive, HER2-negative breast cancers develop ESR1 mutations after treatment. These mutations can make endocrine therapy, also called hormone therapy, less effective. Vepdegestrant offers another option for people whose cancer has grown after earlier hormone-based treatment.

Vepdegestrant is taken by mouth once a day, giving people another oral treatment option for this type of advanced breast cancer.

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How Veppanu Works

Vepdegestrant is a type of treatment called a proteolysis targeting chimera (PROTAC) estrogen receptor degrader. PROTAC drugs are designed to tag specific proteins so the cell can break them down. In vepdegestrant’s case, the target is the estrogen receptor, which can help some breast cancer cells grow.

Vepdegestrant is also the first PROTAC treatment approved by the FDA. This is an important step not just for breast cancer treatment, but also for targeted cancer care overall.

Trial Results Behind the Approval

The approval was based on results from the phase 3 Veritac-2 clinical trial. The study compared vepdegestrant to fulvestrant (Faslodex) in people with ER-positive, HER2-negative advanced or metastatic breast cancer who had previously received endocrine therapy plus a CDK4/6 inhibitor. The trial included 624 people, including 270 whose cancers had ESR1 mutations.

Among people with breast cancer and ESR1 mutations, vepdegestrant helped delay cancer growth longer than fulvestrant. Median progression-free survival — the amount of time before cancer worsened or a person died — was five months with vepdegestrant, compared with 2.1 months with fulvestrant.

This means vepdegestrant reduced the risk of disease progression or death by 43 percent compared to fulvestrant. Researchers need more time to understand whether the treatment helps people live longer.

Side Effects

As with any treatment, vepdegestrant can cause side effects. In clinical trials, the most common side effects and lab changes included:

Low white blood cell counts
Changes in liver blood tests
Muscle and bone pain
Fatigue (extreme tiredness)
Low red blood cell counts
Nausea
Low potassium levels
Decreased appetite
An abnormal electrocardiogram finding called QT prolongation
Low platelet counts
Constipation

A serious possible side effect is a heart rhythm problem called QTc interval prolongation. The treatment may also cause harm to your baby if you are pregnant.

What This Means for People With Advanced Breast Cancer

For people with ER-positive, HER2-negative, ESR1-mutated advanced breast cancer, this approval adds a new oral treatment option after cancer progresses on endocrine therapy. It also shows why testing for gene changes can help doctors choose treatment.

Not every treatment works the same way for every person. If you are not satisfied with your current breast cancer treatment, or if side effects or cancer growth are affecting your quality of life, consider talking with your healthcare provider about your goals, concerns, and available options.