TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and who previously received endocrine therapy and at least two additional treatments for metastatic disease. It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.
In the Phase 3 Study,
TRODELVY HELPED PATIENTS LIVE LONGER THAN TRADITIONAL CHEMOTHERAPY
Patients taking TRODELVY lived
without cancer progressing for
Patients taking TRODELVY lived without cancer progressing for
5.5 Months
compared to 4.0 months for patients
taking traditional chemotherapy
TRODELVY = 272 patients vs traditional
chemotherapy = 271 patients
Slowed the Progression of HR+/HER2- mBC
Some people in the clinical trial taking TRODELVY lived without their cancer growing, spreading, or getting worse for 5.5 months, compared to 4.0 months for people who were treated with traditional chemotherapy. This is called median progression-free survival, which is how long a treatment stops the growth or spread of HR+/HER2- metastatic breast cancer in half of the people who take it.
Traditional chemotherapy consisted of single-agent chemotherapies including eribulin, capecitabine, gemcitabine, or vinorelbine.
Half of patients taking
TRODELVY were still alive at
Half of patients taking TRODELVY were still alive at
14.4 Months
compared to 11.2 months for patients
taking traditional chemotherapy
TRODELVY = 272 patients vs traditional
chemotherapy = 271 patients
Helped People Live Longer
In the clinical trial, TRODELVY helped some people live longer than those who were taking traditional chemotherapy. Some people treated with TRODELVY lived for over 1 year (14.4 months), while some people who received traditional chemotherapy lived for about 11.2 months. This result is called median overall survival (OS), which is how long half of the people are alive after starting treatment.
Traditional chemotherapy consisted of single-agent chemotherapies including eribulin, capecitabine, gemcitabine, or vinorelbine.
Some aspects of quality of life were measured as well
Trodelvy |
Traditional chemotherapy |
|
|---|---|---|
| Overall health and quality of life | 4.3 months (n = 234) | 3.0 months (n = 207) |
| Fatigue | 2.2 months (n = 234) | 1.4 months (n = 205) |
| Pain(There was no statistically significant* difference between the 2 groups for time to pain getting worse) | 3.8 months (n = 229) | 3.5 months (n = 202) |
| n = the number of patients in each group | ||
*To be statistically significant, the difference between 2 groups must be greater than the difference that could happen by chance.
†These results show the median time before worsening. The median is the middle of a set of numbers; in other words, about half of the people in the study experienced these results.
Patients Reported Their Quality of Life and Overall Health Did Not Worsen Until Later
Some people taking TRODELVY reported their quality of life/overall health and fatigue worsened later compared to people who took traditional chemotherapy. Pain was also measured but the time it took for pain to get worse was about the same for both groups, meaning there was no significant* difference between TRODELVY and traditional chemotherapy.†
Health-related quality of life (HRQoL) was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ), a 30-item questionnaire filled out by patients to assess a variety of measures, including overall health/quality of life and symptoms. In this study the time to worsening of quality of life/overall health, fatigue, and pain scores was defined as the median time to these scores worsening by 10 or more points from the start of the study.
Important note: These results should be interpreted with caution since the questionnaire used was not all-inclusive and did not assess all expected treatment-related symptoms or how much the side effects bothered patients. Also, this was an open-label study (doctors and patients knew which treatment they were receiving), and the time to worsening may be unrelated to treatment.
TRODELVY® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and who previously received endocrine therapy and at least two additional treatments for metastatic disease.
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. Severe diarrhea can lead to loss of too much body fluid (dehydration) and kidney problems. 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, your healthcare provider may need to give you fluids and electrolytes to replace body salts. If you develop diarrhea during your treatment with TRODELVY, your healthcare provider should check 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. Tell your healthcare provider right away if you become pregnant during treatment with TRODELVY.
- 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.
- 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 decreased white blood cell (leukocyte and lymphocyte) and red blood cell counts, feeling tired or weak, hair loss, constipation, increased sugar levels in the blood, decreased protein levels (albumin) in the blood, decreased appetite, changes in kidney function test, increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems), and decreased levels of magnesium, potassium, and sodium in the blood.
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.