Unmet Needs in mBC
Pretreated HR+/HER2− mBC and mTNBC are tumor types with historically poor survival and limited treatment options1-3
5-year survival, female breast cancer subtypes, distant metastases1,a
aBased on data from the 2015-2021 SEER 21 database.
HR+/HER2− mBC and mTNBC have some of the lowest 5-year relative survival rates in mBC1
Explore unmet needs by tumor type
mTNBC
Many patients with mTNBC do not receive 2L therapy4
49%
of patients with mTNBC do not receive 2L treatment4
mPFS may range from 5.4 to 5.7 months with traditional 1L chemotherapies5-8,b
aBased on a retrospective, real-world study published in 2025 that analyzed 2004 patients from approximately 280 cancer clinics in the US who were diagnosed with mTNBC from 2011 to 2022.4
bBased upon a meta-analysis of three Phase 3 trials as well as comparator arms of three separate Phase 3 trials with traditional 1L chemotherapies (such as nab-paclitaxel, paclitaxel, or gemcitabine + carboplatin).5-8
Every treatment choice matters
Progression is a common hallmark of TNBC
In a study of 1601 patients with breast cancer (11% with TNBC), a higher percentage of those with TNBC were found to have experienced distant metastases compared with those who had other types of breast cancers.4
Triple-negative breast cancer9
34%
Other breast cancer types9
20%
With limited options available, your next treatment choice is important for your patient1,4
HR+/HER2− mBC
In the postendocrine setting
There is no single standard of care or clearly defined treatment sequence2
Patients with pretreated HR+/HER2− mBC may lose hope with every round of failed treatment. These patients are looking for additional options that may extend survival and quality of life.15
Review mTNBC efficacy and safety data
Review HR+/HER2− mBC efficacy and safety data
2L=second line; HER2=human epidermal growth factor receptor 2; HR=hormone receptor; mBC=metastatic breast cancer; mTNBC=metastatic triple-negative breast cancer; SOC=standard-of-care; TNBC=triple-negative breast cancer.
References: 1. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer stat facts: female breast cancer subtypes. Accessed October 10, 2025. https://seer.cancer.gov/statfacts/html/breast-subtypes.html 2. Moy B, Rumble RB, Come SE, et al. Chemotherapy and targeted therapy for patients with human epidermal growth factor receptor 2–negative metastatic breast cancer that is either endocrine-pretreated or hormone receptor–negative: ASCO guideline update. J Clin Oncol. 2021;39(35):3938-3958. 3. Moy B, Rumble RB, Carey LA. Chemotherapy and targeted therapy for endocrine-pretreated or hormone receptor−negative metastatic breast cancer expert panel: ASCO guideline rapid recommendation update. J Clin Oncol. 2023:41(6):1318-1320. 4. Punie K, Kurian AW, Ntalla I, et al. Unmet need for previously untreated metastatic triple-negative breast cancer: a real-world study of patients diagnosed from 2011 to 2022 in the United States. Oncologist. 2025;30(3):1-12. 5. Miles DW, Dieras V, Cortés J, et al. First-line bevacizumab in combination with chemotherapy for HER2-negative metastatic breast cancer: pooled and subgroup analyses of data from 2447 patients. Ann Oncol. 2013;24:2773-2780. 6. Cortés J, Punie K, Barrios C, et al. Sacituzumab govitecan in untreated, advanced triple-negative breast cancer. N Engl J Med. 2025;393(19):1912-1925. 7. Schmid P, Adams S, Rugo HS, et al. Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer. N Engl J Med. 2018;379:2108-2121. 8. Miles D, Gligorov J, Andre F, et al. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer. Ann Oncol. 2021;32(8):994-1004. 9. Dent R, Trudeau M, Pritchard KI, et al. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res. 2007;13(15, pt 1):4429-4434. 10. Moy B, Rumble RB, Carey LA. Chemotherapy and targeted therapy for HER2-negative metastatic breast cancer that is either endocrine-pretreated or hormone receptor−negative expert panel: ASCO guideline rapid recommendation update. J Clin Oncol. 2022:40(26):3088-3090. 11. Perry S, Kowalski TL, Chang C-H. Quality of life assessment in women with breast cancer: benefits, acceptability and utilization. Health Qual Life Outcomes. 2007;5:24. 12. Wood R, Mitra D, de Courcy J, Iyer S. Patient-reported quality of life and treatment satisfaction in patients with HR+/HER2- advanced/metastatic breast cancer. Clin Ther. 2017;39(8):1719-1728. 13. Walker MS, Hasan M, Yim YM, Yu E, Stepanski EJ, Schwartzberg LS. Retrospective study of the effect of disease progression on patient reported outcomes in HER-2 negative metastatic breast cancer patients. Health Qual Life Outcomes. 2011;9:46. 14. Burstein HJ, Somerfield MR, Barton DL, et al. Endocrine treatment and targeted therapy for hormone receptor-positive, human epidermal growth factor receptor 2−negative metastatic breast cancer: ASCO guideline update. J Clin Oncol. 2021;39(35):3959-3977. 15. Mosher CE, Johnson C, Dickler M, Norton L, Massie MJ, DuHamel K. Living with metastatic breast cancer: a qualitative analysis of physical, psychological, and social sequelae. Breast J. 2013;19(3):285-292.
TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2–directed antibody and topoisomerase inhibitor conjugate indicated in adult patients:
Locally Advanced or Metastatic Triple-Negative Breast Cancer
First Line
- As a single agent for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy
- In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of unresectable locally advanced or mTNBC whose tumors express PD-L1 [Combined Positive Score (CPS ≥10)] as determined by an FDA-authorized test
Second Line or Later
- For the treatment of unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Locally Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
- For the treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Important Safety Information
Tap for Important Safety Information, including BOXED WARNING: Neutropenia and Diarrhea.
Boxed Warning: neutropenia and diarrhea
- TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
- TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤Grade 1 and reduce subsequent doses.
Contraindications
- Severe hypersensitivity reaction to TRODELVY.
Warnings and precautions
Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 48% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.
Diarrhea: Diarrhea occurred in 62% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 10% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.6% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and, if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (eg, fluid and electrolyte replacement) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (eg, atropine) for subsequent treatments.
Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions, including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, and skin reactions. Hypersensitivity reactions occurred in 28% of patients with 13% occurring within 24 hours of dosage. Grade 3-4 hypersensitivity occurred in 1.5% of patients with 0.4% of these occurring within 24 hours of dosage. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.4%. The incidence of anaphylactic reaction was <0.1%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Closely monitor patients for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.
Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 63% of all patients treated with TRODELVY, and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 33% of patients, and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two- or three-drug combination regimen (eg, dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist, as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting. Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to ≤Grade 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.
Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 57% in patients homozygous for the UGT1A1*28 allele, 48% in patients heterozygous for the UGT1A1*28 allele, and 41% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 17% in patients homozygous for the UGT1A1*28 allele, 9% in patients heterozygous for the UGT1A1*28 allele, and 8% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration, and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.
Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.
Adverse Reactions
In the pooled safety population of TRODELVY as a single agent, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased leukocyte count (83%), decreased neutrophil count (77%), decreased hemoglobin (71%), nausea (63%), diarrhea (62%), decreased lymphocyte count (60%), fatigue (59%), alopecia (47%), increased glucose (40%), constipation (37%), vomiting (33%), decreased albumin (32%), increased alkaline phosphatase (30%), decreased appetite (28%), abdominal pain (27%), decreased creatinine clearance (27%), decreased magnesium and potassium (26% each).
In the safety population of TRODELVY in combination with pembrolizumab, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count and hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and glucose (50% each), increased alanine aminotransferase (47%), constipation (41%), increased aspartate aminotransferase (40%), rash (37%), decreased potassium (35%), increased lactate dehydrogenase (34%), vomiting (29%), abdominal pain, headache, and increased eosinophils (26% each), and decreased albumin (25%).
In the ASCENT-03 study (single agent in previously untreated, unresectable locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were nausea, diarrhea, alopecia, fatigue, constipation, and vomiting. The most frequent serious adverse reactions (SAR) (>2%) were diarrhea, febrile neutropenia, and neutropenia (3.6% each), and pneumonia (2.9%). SAR occurred in 26% of patients, and 3.6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.5% of patients and included sepsis (1.1%), and acute respiratory failure, neutropenic colitis, pneumonia, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
In the ASCENT-04 study (in combination with pembrolizumab in previously untreated, unresectable locally advanced or mTNBC whose tumors express PD-L1), the most common adverse reactions (incidence ≥25%) were diarrhea, nausea, fatigue, alopecia, constipation, rash, vomiting, abdominal pain, and headache. The most frequent SAR (≥2%) were febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), and fatigue and pneumonia (2.3% each). SAR occurred in 38% of patients, and 7% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 3.2% of patients and included death (unknown cause) (0.9%) and completed suicide, neutropenic sepsis, sepsis, pneumonia, and pulmonary embolism (0.5% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
In the ASCENT study (previously treated locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent SAR (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR occurred in 27% of patients, and 5% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 1.2% of patients and included respiratory failure (0.8%) and pneumonia (0.4%). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils, leukocytes, and lymphocytes.
In the TROPiCS-02 study (locally advanced or metastatic HR+/HER2– breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent SAR (>1%) were diarrhea (5%), febrile neutropenia (4.1%), neutropenia (3%), abdominal pain (2.2%), neutropenic colitis and vomiting (1.9% each), and colitis and pneumonia (1.5% each). SAR occurred in 28% of patients, and 6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.2% of patients and included arrhythmia, COVID-19 pneumonia, pneumonia, nervous system disorder, pulmonary embolism, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
Drug Interactions
UGT1A1 Inhibitors: Avoid administering UGT1A1 inhibitors with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38.
UGT1A1 Inducers: Avoid administering UGT1A1 inducers with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inducers of UGT1A1 may reduce exposure to SN-38.
Please see full Prescribing Information, including BOXED WARNING.
TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2–directed antibody and topoisomerase inhibitor conjugate indicated in adult patients:
Locally Advanced or Metastatic Triple-Negative Breast Cancer
First Line
- As a single agent for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy
- In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of unresectable locally advanced or mTNBC whose tumors express PD-L1 [Combined Positive Score (CPS ≥10)] as determined by an FDA-authorized test
Second Line or Later
- For the treatment of unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Locally Advanced or Metastatic HR-positive, HER2-negative Breast Cancer
- For the treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Important Safety Information
Tap for Important Safety Information, including BOXED WARNING: Neutropenia and Diarrhea.
Boxed Warning: neutropenia and diarrhea
- TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
- TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤Grade 1 and reduce subsequent doses.
Contraindications
- Severe hypersensitivity reaction to TRODELVY.
Warnings and precautions
Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 48% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.
Diarrhea: Diarrhea occurred in 62% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 10% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.6% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and, if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (eg, fluid and electrolyte replacement) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (eg, atropine) for subsequent treatments.
Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions, including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, and skin reactions. Hypersensitivity reactions occurred in 28% of patients with 13% occurring within 24 hours of dosage. Grade 3-4 hypersensitivity occurred in 1.5% of patients with 0.4% of these occurring within 24 hours of dosage. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.4%. The incidence of anaphylactic reaction was <0.1%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Closely monitor patients for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.
Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 63% of all patients treated with TRODELVY, and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 33% of patients, and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two- or three-drug combination regimen (eg, dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist, as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting. Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to ≤Grade 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.
Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 57% in patients homozygous for the UGT1A1*28 allele, 48% in patients heterozygous for the UGT1A1*28 allele, and 41% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 17% in patients homozygous for the UGT1A1*28 allele, 9% in patients heterozygous for the UGT1A1*28 allele, and 8% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration, and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.
Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.
Adverse Reactions
In the pooled safety population of TRODELVY as a single agent, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased leukocyte count (83%), decreased neutrophil count (77%), decreased hemoglobin (71%), nausea (63%), diarrhea (62%), decreased lymphocyte count (60%), fatigue (59%), alopecia (47%), increased glucose (40%), constipation (37%), vomiting (33%), decreased albumin (32%), increased alkaline phosphatase (30%), decreased appetite (28%), abdominal pain (27%), decreased creatinine clearance (27%), decreased magnesium and potassium (26% each).
In the safety population of TRODELVY in combination with pembrolizumab, the most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count and hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and glucose (50% each), increased alanine aminotransferase (47%), constipation (41%), increased aspartate aminotransferase (40%), rash (37%), decreased potassium (35%), increased lactate dehydrogenase (34%), vomiting (29%), abdominal pain, headache, and increased eosinophils (26% each), and decreased albumin (25%).
In the ASCENT-03 study (single agent in previously untreated, unresectable locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were nausea, diarrhea, alopecia, fatigue, constipation, and vomiting. The most frequent serious adverse reactions (SAR) (>2%) were diarrhea, febrile neutropenia, and neutropenia (3.6% each), and pneumonia (2.9%). SAR occurred in 26% of patients, and 3.6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.5% of patients and included sepsis (1.1%), and acute respiratory failure, neutropenic colitis, pneumonia, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
In the ASCENT-04 study (in combination with pembrolizumab in previously untreated, unresectable locally advanced or mTNBC whose tumors express PD-L1), the most common adverse reactions (incidence ≥25%) were diarrhea, nausea, fatigue, alopecia, constipation, rash, vomiting, abdominal pain, and headache. The most frequent SAR (≥2%) were febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), and fatigue and pneumonia (2.3% each). SAR occurred in 38% of patients, and 7% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 3.2% of patients and included death (unknown cause) (0.9%) and completed suicide, neutropenic sepsis, sepsis, pneumonia, and pulmonary embolism (0.5% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
In the ASCENT study (previously treated locally advanced or mTNBC), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent SAR (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR occurred in 27% of patients, and 5% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 1.2% of patients and included respiratory failure (0.8%) and pneumonia (0.4%). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils, leukocytes, and lymphocytes.
In the TROPiCS-02 study (locally advanced or metastatic HR+/HER2– breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent SAR (>1%) were diarrhea (5%), febrile neutropenia (4.1%), neutropenia (3%), abdominal pain (2.2%), neutropenic colitis and vomiting (1.9% each), and colitis and pneumonia (1.5% each). SAR occurred in 28% of patients, and 6% permanently discontinued TRODELVY due to adverse reactions. Fatal adverse reactions occurred in 2.2% of patients and included arrhythmia, COVID-19 pneumonia, pneumonia, nervous system disorder, pulmonary embolism, and septic shock (0.4% each). The most common Grade 3-4 lab abnormalities (incidence ≥25%) were decreased neutrophils and leukocytes.
Drug Interactions
UGT1A1 Inhibitors: Avoid administering UGT1A1 inhibitors with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38.
UGT1A1 Inducers: Avoid administering UGT1A1 inducers with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inducers of UGT1A1 may reduce exposure to SN-38.
Please see full Prescribing Information, including BOXED WARNING.