Efficacy

ONE-THIRD OF PATIENTS HAD THEIR TUMORS SHRINK

TRODELVY was studied in 108 patients with metastatic triple-negative breast cancer (mTNBC) who had at least 2 prior treatments for their metastatic disease.

  • Patients with bulky disease, defined as a mass >7 cm, were not eligible
  • Patients with treated brain metastases not receiving a high dose of steroids (>20 mg prednisone or equivalent) for at least 4 weeks were eligible
  • Patients with known Gilbert's disease were excluded
Graphic showing that 33.3% of patients saw their tumors shrink
Graphic showing that response to treatment lasted 7.7 months

TRODELVY was studied across a range of patients:

  • The median age was 55 years (range 31-80 ); 87% of patients were younger than 65 years
  • The majority of patients were female (99%) and White (76%)
  • The median number of prior metastatic therapies was 3. The range was 2-10

A larger clinical trial is being conducted to help confirm the clinical benefit of TRODELVY.

What is TRODELVY?

TRODELVY™ (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with a certain type of breast cancer known as triple-negative (HR and HER2 negative) that has spread to other parts of the body (metastatic) and who received at least two therapies for metastatic disease.

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 (neutropenia). Low white blood cell counts are common with TRODELVY and can sometimes be severe and lead to infections that can be life-threatening. Your healthcare provider should check your blood cell counts during treatment with TRODELVY. If your white blood cell count is too low, your healthcare provider may need to lower your dose of TRODELVY, 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 during treatment with TRODELVY: fever, chills, cough, shortness of breath, or burning or pain when you urinate.
  • Severe diarrhea. Diarrhea is common with TRODELVY and can also be severe. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control your diarrhea. If you lose too much body fluids (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 the diarrhea 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 losing too much body fluid (dehydration) and body salts, 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. TRODELVY can cause severe and life-threatening allergic reactions during infusion (infusion-related reactions). Tell your healthcare provider or nurse right away if you get any of the following symptoms of an allergic reaction during an infusion of TRODELVY or within 24 hours after you receive a dose of TRODELVY: swelling of your face, lips, tongue, or throat; hives; skin rash or flushing of your skin; difficulty breathing or wheezing; lightheadedness, dizziness, feeling faint, or pass out; chills or shaking chills (rigors); or fever.

Nausea and vomiting. 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. You should be given medicines to take home with you, along with instructions about how to take them to help prevent and treat any nausea and vomiting after you receive TRODELVY. 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 uridine diphosphate-glucuronosyl transferase A1 (UGT1A1)*28. People who carry this gene have an increased risk of getting side effects with TRODELVY, especially low white 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 nausea, low white blood cells (neutropenia), diarrhea, tiredness, decreased red blood cell count, vomiting, hair loss, constipation, rash, decreased appetite, stomach-area (abdomen) pain and respiratory infections.

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 see full Prescribing Information and Patient Information, including boxed Warning.

What is TRODELVY?

TRODELVY™ (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with a certain type of breast cancer known as triple-negative (HR and HER2 negative) that has spread to other parts of the body (metastatic) and who received at least two therapies for metastatic disease.

TRODELVY is approved based on tumor response. Data are not yet available to show if TRODELVY improves survival or symptoms.

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 (neutropenia). Low white blood cell counts are common with TRODELVY and can sometimes be severe and lead to infections that can be life-threatening. Your healthcare provider should check your blood cell counts during treatment with TRODELVY. If your white blood cell count is too low, your healthcare provider may need to lower your dose of TRODELVY, 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 during treatment with TRODELVY: fever, chills, cough, shortness of breath, or burning or pain when you urinate.
  • Severe diarrhea. Diarrhea is common with TRODELVY and can also be severe. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control your diarrhea. If you lose too much body fluids (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 the diarrhea 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 losing too much body fluid (dehydration) and body salts, 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.

What is TRODELVY?

 

TRODELVY™ (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with a certain type of breast cancer known as triple-negative (HR and HER2 negative) that has spread to other parts of the body (metastatic) and who received at least two therapies for metastatic disease.

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 (neutropenia). Low white blood cell counts are common with TRODELVY and can sometimes be severe and lead to infections that can be life-threatening. Your healthcare provider should check your blood cell counts during treatment with TRODELVY. If your white blood cell count is too low, your healthcare provider may need to lower your dose of TRODELVY, 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 during treatment with TRODELVY: fever, chills, cough, shortness of breath, or burning or pain when you urinate.
  • Severe diarrhea. Diarrhea is common with TRODELVY and can also be severe. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control your diarrhea. If you lose too much body fluids (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 the diarrhea 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 losing too much body fluid (dehydration) and body salts, 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. TRODELVY can cause severe and life-threatening allergic reactions during infusion (infusion-related reactions). Tell your healthcare provider or nurse right away if you get any of the following symptoms of an allergic reaction during an infusion of TRODELVY or within 24 hours after you receive a dose of TRODELVY: swelling of your face, lips, tongue, or throat; hives; skin rash or flushing of your skin; difficulty breathing or wheezing; lightheadedness, dizziness, feeling faint, or pass out; chills or shaking chills (rigors); or fever.

Nausea and vomiting. 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. You should be given medicines to take home with you, along with instructions about how to take them to help prevent and treat any nausea and vomiting after you receive TRODELVY. 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 uridine diphosphate-glucuronosyl transferase A1 (UGT1A1)*28. People who carry this gene have an increased risk of getting side effects with TRODELVY, especially low white 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 nausea, low white blood cells (neutropenia), diarrhea, tiredness, decreased red blood cell count, vomiting, hair loss, constipation, rash, decreased appetite, stomach-area (abdomen) pain and respiratory infections.

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 see full Prescribing Information and Patient Information, including boxed Warning.