TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract that have spread (metastatic) or cannot be removed by surgery, and who have received a platinum-containing chemotherapy medicine and also received an immunotherapy medicine. TRODELVY is approved based on medical studies that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in additional medical studies. It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.
Advanced Bladder Cancer
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Designed to concentrate on certain cells

TRODELVY is a type of treatment called an antibody-drug conjugate (ADC) that is designed to work differently than traditional chemotherapy. It is designed to deliver powerful anticancer medicine directly into cells with Trop-2 proteins.

Information from laboratory studies suggest that this is how TRODELVY works. The clinical benefit of these observations is unknown.

TRODELVY is Y-shaped and is designed to carry cancer-fighting medicine to cancer cells that have Trop-2 proteins.
A diagram representing the TRODELVY molecule. A green Y-shaped illustration represents the antibody. Yellow pins attached to the Y-shape represent the linkers that carry anticancer medicine.
Tumor cells in certain cancers have a higher amount of Trop-2 proteins for TRODELVY to link to.
A diagram representing how TRODELVY attaches to a cancer cell. A blue circle representing the cancer cell has multiple Trop-2 proteins around the outside. The Y-shaped TRODELVY molecule is attached to one of the proteins.
An ADC is a substance that binds to a specific protein or receptor found on certain types of cells, including cancer cells. It has 3 parts: an antibody that looks for Trop-2 proteins, an anticancer drug, and a linker that connects the antibody to the drug.

HOW TRODELVY WORKS

Understanding what makes each treatment different can be confusing. This video will help break down the science to show you how TRODELVY is designed to work. Think of TRODELVY like a cargo ship designed to deliver anticancer medicine directly to cells with Trop-2 proteins. Watch to learn about TRODELVY from an oncologist and some unexpected guests.

TRODELVY IS DESIGNED TO DELIVER ANTICANCER MEDICINE INTO CELLS

Scientists discovered that patients with certain types of cancer have tumor cells that often contain more Trop-2 protein than normal cells (or noncancer cells). TRODELVY binds to cells with Trop-2.

A diagram showing 4 Y-shaped TRODELVY molecules attaching to the Trop-2 proteins on the outside of a cancer cell.

Seeks out.

TRODELVY attaches to Trop-2

A diagram representing how TRODELVY enters the cancer cell.

Breaks in.

Once attached, TRODELVY enters the cancer cell

A diagram showing a cancer cell breaking apart as TRODELVY releases the anticancer medicine from inside the cell.

Destroys.

Once TRODELVY enters, the anticancer medicine is released, killing the cell

What is TRODELVY?

TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract that have spread (metastatic) or cannot be removed by surgery, and who have received a platinum-containing chemotherapy medicine and also received an immunotherapy medicine.

TRODELVY is approved based on medical studies that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in additional medical studies.

It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.

Important Safety Information

TRODELVY can cause serious side effects, including low white blood cell count and diarrhea:
  • Low white blood cell count (neutropenia) which is common and can sometimes be severe and lead to infections that can be life-threatening or cause death. Your healthcare provider should check your blood cell counts during treatment. If your white blood cell count is too low, your healthcare provider may need to lower your dose, give you a medicine to help prevent low blood cell count with future doses of TRODELVY, or in some cases may stop TRODELVY. Your healthcare provider may need to give you antibiotic medicines if you develop fever while your white blood cell count is low. Call your healthcare provider right away if you develop any of the following signs of infection: fever, chills, cough, shortness of breath, or burning or pain when you urinate.
  • Severe diarrhea. Diarrhea is common and can be severe. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control it. If you lose too much body fluid (dehydration), your healthcare provider may need to give you fluids and electrolytes to replace body salts. If diarrhea happens later in your treatment, your healthcare provider may check you to see if it may be caused by an infection. Your healthcare provider may decrease your dose or stop TRODELVY if your diarrhea is severe and cannot be controlled with anti-diarrheal medicines.
    • Call your healthcare provider right away the first time that you get diarrhea during treatment with TRODELVY; if you have black or bloody stools; if you have symptoms of dehydration, such as lightheadedness, dizziness, or faintness; if you are unable to take fluids by mouth due to nausea or vomiting; or if you are not able to get your diarrhea under control within 24 hours.

Do not receive TRODELVY if you have had a severe allergic reaction to TRODELVY. Ask your healthcare provider if you are not sure.

Allergic and infusion-related reactions which can be serious and life-threatening. Tell your healthcare provider or nurse right away if you get any of the following symptoms during your infusion of TRODELVY or within 24 hours after: swelling of your face, lips, tongue, or throat; hives; skin rash, itching, or flushing of your skin; fever; difficulty breathing or wheezing; lightheadedness, dizziness, feeling faint, or pass out; or chills or shaking chills (rigors).

Nausea and vomiting are common with TRODELVY and can sometimes be severe. Before each dose of TRODELVY, you will receive medicines to help prevent nausea and vomiting along with medicines to take home with instructions about how to take them. Call your healthcare provider right away if you have nausea or vomiting that is not controlled with the medicines prescribed for you. Your healthcare provider may decide to decrease your dose or stop TRODELVY if your nausea and vomiting is severe and cannot be controlled with anti-nausea medicines.

Before receiving TRODELVY, tell your healthcare provider about all of your medical conditions, including if you:

  • have been told that you carry a gene for UGT1A1*28, which can increase your risk of getting side effects with TRODELVY, especially low white blood cell counts, with or without a fever, and low red blood cell counts.
  • have liver problems.
  • are pregnant or plan to become pregnant. TRODELVY can harm your unborn baby. Your healthcare provider should check to see if you are pregnant before you start receiving TRODELVY. TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your healthcare provider if fertility is a concern for you.
    • Females who can become pregnant should use effective birth control during treatment and for 6 months after your last dose of TRODELVY. Talk to your healthcare provider about birth control choices that may be right for you during this time.
    • Males with a female partner who can become pregnant should use effective birth control during treatment and for 3 months after your last dose of TRODELVY.
    • Tell your healthcare provider right away if you or your partner become pregnant during treatment with TRODELVY.
  • are breastfeeding or plan to breastfeed. It is not known if TRODELVY passes into your breastmilk and can harm your baby. Do not breastfeed during treatment and for 1 month after your last dose of TRODELVY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect the way TRODELVY works.

The most common side effects of TRODELVY include feeling tired or weak, hair loss, decreased red blood cell count, constipation, decreased appetite, rash, and stomach-area (abdominal) pain or discomfort.

These are not all of the possible side effects of TRODELVY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please click to see Important Facts about TRODELVY, including Important Warning.