FDA Approves Vepdegestrant for Metastatic ER-Positive Breast Cancer
On May 1, 2026, the U.S. Food and Drug Administration (FDA) approved vepdegestrant (brand name: Veppanu) to treat estrogen receptor-positive, HER2-negative advanced stage or metastatic breast cancer with an ESR1 mutation that grew after being treated with hormonal therapy.
The approval was based on results from the VERITAC-2 trial, which compared vepdegestrant to Faslodex (chemical name: fulvestrant). The results showed that vepdegestrant was more effective for people with metastatic estrogen receptor-positive, HER2-negative breast cancer with an ESR1 mutation that grew while being treated with hormonal therapy and a CDK4/6 inhibitor. The people in the study who took vepdegestrant lived three months longer without the cancer growing than those who received Faslodex. And more of the cancers responded to vepdegestrant than Faslodex — 19% vs. 4%.
How vepdegestrant works
Vepdegestrant is a new type of oral selective estrogen receptor downregulator or degrader (SERD) called a PROTAC (proteolosys-targeting chimera). Like other SERDs, vepdegestrant works by blocking estrogen from attaching to cancer cells in the breast. It also destroys the estrogen receptors on the cancer cells and changes the shape of the receptors so they don’t work as well. Because it is a PROTAC, it breaks down the estrogen receptors in a different way than other SERDs.
Up to 40% of advanced-stage or metastatic, estrogen receptor-positive, HER2-negative breast cancers develop an ESR1 mutation while being treated with hormonal therapy. This mutation makes the cancer resistant to hormonal therapy medicines commonly used as first treatments: aromatase inhibitors and selective estrogen receptor modulators (SERMs), like tamoxifen.
Vedegestrant is a pill taken by mouth. The recommended dose is 200 mg once per day with food.
Vepdegestrant side effects
Like nearly all breast cancer medicines, vepdegestrant can cause side effects, some of them severe.
The most common side effects of vepdegestrant are:
Vepdegestrant also may cause a heart problem known as QT interval prolongation. The QT interval is a measurement made on an electrocardiogram, or EKG, used to evaluate some of your heart’s electrical properties. This can lead to a fast or irregular heartbeat, which may be life-threatening. People taking vepdegestrant need to have an EKG every couple of weeks during treatment.
Vepdegestrant can also be harmful to a fetus. You should not take vepdegestrant if you’re pregnant, trying to get pregnant, or if there is any chance that you could be pregnant. Women should use an effective non-hormonal type of birth control while taking vepdegestrant. Ask your doctor which type of non-hormonal birth control would be best for you. Women should use birth control for at least two weeks after their last dose of vepdegestrant.
You shouldn’t breastfeed while taking vepdegestrant and should wait at least two weeks after your last dose to start breastfeeding.
If you’re a man taking vepdegestrant and have a partner who can become pregnant, your partner should use birth control while you’re taking vepdegestrant and for at least two weeks after your last dose.
Vepdegestrant drug interactions
There are certain medicines and supplements you should avoid if you’re taking vepdegestrant. It’s important to tell your doctor about all medicines, vitamins, and supplements you take — even if they’re not on this list — so they can determine whether vepdegestrant is right for you.
CYP3A inducers
You shouldn’t take CYP3A inducers because they decrease the effects of vepdegestrant. This class of medicine includes Rifamate (chemical name: rifampin), an antibiotic used to treat tuberculosis, and Carbatrol (chemical name: carbamazepine), which is used to control certain types of seizures in people with epilepsy. St. John’s wort, an herbal supplement, is also considered a CYP3A inducer.
CYP3A inhibitors
CYP3A inhibitors increase the effects of vepdegestrant. This class of medicine includes Nizoral (chemical name: ketoconazole) and Sporanox (chemical name: itraconazole), which are used to treat fungal infections; Reyataz (chemical name: atazanavir), used to treat HIV; and nefazodone, used to treat depression. Grapefruit and goldenseal, an herbal supplement, are also CYP3A inhibitors.
P-gp substrates
Vepdegestrant can increase the effects of P-gp substrate medicines. This class of medicine includes cyclosporine, which is used to prevent organ transplant rejection, digoxin, which is used to treat heart failure, and many statins.
UGT1A9 substrates
Vepdegestrant can increase the effects of UGT1A9 substrate medicines. This class of medicine includes the anesthetic propofol and the pain medicine acetaminophen.
Paying for vepdegestrant
The cost of vepdegestrant may vary. The price you’ll pay depends on your health insurance provider and plan, where you live, and the pharmacy you use.
Note: Your insurance company may require you to get prior authorization before covering vepdegestrant.
If your doctor prescribes vepdegestrant and you have problems paying for it or getting health insurance coverage, Pfizer, one of the companies that developed vepdegestrant, has the PfizerForAll program that may be able to help.
Learn more about financial assistance and tips for lowering medicine costs.