TRODELVY

1 INDICATIONS AND USAGE TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated: Locally Advanced or Metastatic Triple-Negative Breast Cancer First Line As a single agent for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. ( 1.1 , 14.1 ) In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥ 10) as determined by an FDA-authorized test. ( 1.1 , 14.1 ) Second Line or Later For the treatment of adult patients with unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. ( 1.1 , 14.1 ) Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer For the treatment of adult patients with 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. ( 1.1 , 14.2 ) 1.1 Locally Advanced or Metastatic Triple-Negative Breast Cancer First Line TRODELVY as a single agent is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor based therapy. TRODELVY, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 [Combined Positive Score (CPS ≥ 10)] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . Second Line or Later TRODELVY is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. 1.2 Locally Advanced or Metastatic HR-positive, HER2-negative Breast Cancer TRODELVY is indicated for the treatment of adult patients with 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.

2 DOSAGE AND ADMINISTRATION Do NOT substitute TRODELVY for or use with other drugs containing irinotecan or its active metabolite SN-38. ( 2 ) Premedication for prevention of infusion reactions and of chemotherapy-induced nausea and vomiting is recommended. ( 2.1 ) The recommended dosage as a single agent or in combination with pembrolizumab is 10 mg/kg on Days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity. ( 2.3 ) Monitor patients during the infusion and for at least 30 minutes after completion of infusion. Treatment interruption and/or dose reduction may be needed to manage adverse reactions. ( 2.4 , 2.5 ) See Full Prescribing Information for preparation and administration instructions. ( 2.4 ) 2.1 Important Use Information and Premedication Do NOT substitute TRODELVY for or use with other drugs containing irinotecan or its active metabolite SN-38. Premedication Prior to each dose of TRODELVY, premedication for prevention of infusion reactions and of chemotherapy-induced nausea and vomiting (CINV) is recommended. Premedicate with antipyretics, H1 and H2 blockers prior to infusion, and corticosteroids may be used for patients who had prior infusion reactions. Premedicate with a 2 or 3 drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK 1 receptor antagonist, as well as other drugs as indicated). Prophylaxis for Neutropenia Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) is recommended starting in the first cycle for all patients at increased risk of febrile neutropenia [see Warnings and Precautions (5.1) ] . 2.2 Patient Selection for Combination Therapy Select patients for treatment of unresectable locally advanced or metastatic TNBC with TRODELVY in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, based on the tumor expression of PD-L1 as confirmed by an FDA-authorized test [see Clinical Studies (14.1) ] . Information on FDA-authorized tests is available at http://www.fda.gov/companiondiagnostics . 2.3 Recommended Dosage The recommended dosage of TRODELVY as a single agent or in combination with pembrolizumab is 10 mg/kg administered as an intravenous infusion on Days 1 and 8 of each 21-day cycle. Continue TRODELVY until disease progression or unacceptable toxicity. Do not administer TRODELVY at doses greater than 10 mg/kg. When TRODELVY is administered in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, discontinue pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, after approximately 24 months. Refer to the Prescribing Information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the recommended dosing information. 2.4 Dosage Modifications for Adverse Reactions Management of adverse reactions may require temporary interruption, dose reduction, or permanent discontinuation of TRODELVY as described in Tables 1 and 2. Do not re-escalate the TRODELVY dose after a dose reduction for adverse reactions has been made. Table 1: Dosage Reduction Levels Dose Reduction Permanently discontinue TRODELVY in patients unable to tolerate 5 mg/kg. Dosage and Schedule First Reduce to 7.5 mg/kg Second Reduce to 5 mg/kg The recommended dosage modifications for adverse reactions are provided in Table 2. Table 2: Dosage Modifications for Adverse Reactions Adverse reactions Severity Dose Modification Neutropenia [see Warnings and Precautions (5.1) ] Grade 3-4 neutropenia (Absolute Neutrophil Count [ANC] <1,000/mm 3 ) or febrile neutropenia Withhold TRODELVY until ANC ≥1500/mm 3 for Day 1 dose or ANC ≥1000/mm 3 for Day 8 Dose Administer G-CSF during treatment as clinically indicated. Reduce one dose level for each occurrence of febrile neutropenia or prolonged Grade 3-4 neutropenia, or permanently discontinue according to Table 1. Nausea/Vomiting/ Diarrhea [see Warnings and Precautions (5.2 , 5.4) ] Grade 3-4 nausea, vomiting or diarrhea that is not controlled with antiemetics or anti-diarrheal agents Withhold TRODELVY until resolved to ≤ Grade 1 Reduce one dose level with each occurrence, or permanently discontinue according to Table 1. Infusion-Related Reaction [see Warnings and Precautions (5.3) ] Grade 1-3 infusion-related reactions Slow infusion rate or interrupt the infusion Grade 4 infusion-related reactions Permanently discontinue TRODELVY. Other Toxicities Other Grade 3-4 toxicities of any duration despite optimal medical management Withhold TRODELVY until resolved to ≤ Grade 1 Reduce one dose level with each occurrence or permanently discontinue according to Table 1. Dosage Modifications for Adverse Reactions for TRODELVY in Combination with Pembrolizumab or Pembrolizumab and berahyaluronidase alfa-pmph Interrupt or discontinue one or both drugs of the combination or reduce the dose of TRODELVY to manage adverse reactions as appropriate. Refer to the prescribing information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for recommendations on dosage interruption or discontinuation due to adverse reactions. For TRODELVY dosage modifications, refer to Table 1 and Table 2. 2.5 Preparation and Administration Reconstitution TRODELVY is a hazardous drug. Follow applicable special handling and disposal procedures 1 . Calculate the required dose (mg) of TRODELVY based on the patient's current body weight [see Dosage and Administration (2.2) ] . Using a sterile syringe, slowly inject 20 mL of 0.9% Sodium Chloride Injection, USP, into each 180 mg TRODELVY vial. Each vial contains overfill to compensate for liquid loss during preparation and after reconstitution, the total resulting volume delivers a concentration of 10 mg/mL . Gently swirl vials and allow to dissolve for up to 15 minutes. Do not shake . Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be free of visible particulates, clear and yellow. Do not use the reconstituted solution if it is cloudy or discolored. Use reconstituted TRODELVY immediately to prepare a diluted TRODELVY infusion solution. Dilution Calculate the required amount of the reconstituted TRODELVY solution needed to obtain the appropriate dose according to the patient's body weight. Determine the final volume of the infusion solution to deliver the appropriate dose at a TRODELVY concentration range of 1.1 mg/mL to 3.4 mg/mL. Use 0.9% Sodium Chloride Injection, USP only since the stability of the reconstituted TRODELVY solution has not been determined with other infusion-based solutions. Use a polyvinyl chloride, polypropylene/polyethylene, polyolefin, or ethylene vinyl acetate infusion bag. Withdraw and discard the volume of 0.9% Sodium Chloride Injection, USP from the final infusion bag that is necessary to achieve the indicated TRODELVY concentration following the addition of the calculated amount of reconstituted TRODELVY solution. Withdraw the calculated amount of the reconstituted TRODELVY solution from the vial(s) using a syringe. Discard any unused portion remaining in the vial(s). To minimize foaming, slowly inject the calculated amount of reconstituted TRODELVY solution into the infusion bag. Do not shake the contents. If not used immediately, the infusion bag containing TRODELVY solution can be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours protected from light. After refrigeration, administer diluted solution at room temperature up to 25°C (77°F) within 8 hours (including infusion time). Do Not Freeze or Shake. Administration Administer TRODELVY as an intravenous infusion. First infusion: Administer over 3 hours. Observe patients during the infusion and for at least 30 minutes following the initial dose, for signs or symptoms of infusion-related reactions [see Warning and Precautions (5.3) ] . Second and subsequent infusions : Administer over 1 to 2 hours if prior infusions were tolerated. Observe patients during the infusion and for at least 30 minutes after infusion. Protect infusion bag from light. The infusion bag should be covered during administration to the patient until dosing is complete. It is not necessary to cover the infusion tubing or to use light-protective tubing during the infusion. An infusion pump may be used. Do not mix TRODELVY, or administer in the same intravenous line, with other medicinal products. Upon completion of the infusion, flush the intravenous line with 20 mL 0.9% Sodium Chloride Injection, USP.

4 CONTRAINDICATIONS TRODELVY is contraindicated in patients who have experienced a severe hypersensitivity reaction to TRODELVY [see Warnings and Precautions (5.3) ] . Severe hypersensitivity reaction to TRODELVY. ( 4 , 5.3 )

5 WARNINGS AND PRECAUTIONS Hypersensitivity and Infusion-Related Reactions : Hypersensitivity reactions including severe anaphylactic reactions have been observed. Monitor patients for infusion-related reactions. Permanently discontinue TRODELVY if severe or life-threatening reactions occur. ( 5.3 ) Nausea/Vomiting : Use antiemetic preventive treatment and withhold TRODELVY for patients with Grade 3 nausea or Grade 3-4 vomiting at the time of scheduled treatment. ( 5.4 ) Patients with Reduced UGT1A1 Activity : Individuals who are homozygous for the UGT1A1*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia following initiation of TRODELVY. ( 5.5 ) Embryo-Fetal Toxicity : TRODELVY can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ( 5.6 , 8.1 , 8.3 ) 5.1 Neutropenia TRODELVY can cause severe, life-threatening, or fatal neutropenia as early as the first cycle of treatment. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 48% of patients. Febrile neutropenia occurred in 6% of patients. The median time to first onset of neutropenia (including febrile neutropenia) was 19 days (range: 1 to 1022 days). Neutropenia occurred earlier in patients with reduced UGT1A1 activity [see Warnings and Precautions (5.5) ] . Neutropenic colitis occurred in 1.4% of patients. 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 [see Dosage and Administration (2.1) ] . Monitor absolute neutrophil count (ANC) during treatment. Withheld TRODELVY for ANC below 1500/mm 3 on Day 1 of any cycle or below 1000/mm 3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Dose modifications may be required due to neutropenia. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 [see Dosage and Administration (2.4) ] . 5.2 Diarrhea TRODELVY can cause severe diarrhea. Diarrhea occurred in 62% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 10% of all patients treated with TRODELVY. 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 at the time of scheduled treatment administration and resume when resolved to ≤ Grade 1 [see Dosage and Administration (2.4) ]. At the onset of diarrhea, 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 (e.g., fluid and electrolyte replacement) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment with TRODELVY (e.g., abdominal cramping, diarrhea, salivation, etc.) can receive appropriate premedication (e.g., atropine) for subsequent treatments. 5.3 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 [see Contraindications (4) ] . Hypersensitivity reactions occurred in 28% of patients treated with TRODELVY with 13% occurring within 24 hours of dosage. Grade 3-4 hypersensitivity occurred in 1.5% of patients treated with TRODELVY 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%. Premedication for infusion reactions in patients receiving TRODELVY is recommended . Have medications and emergency equipment to treat infusion-related reactions, including anaphylaxis, available for immediate use when administering TRODELVY [see Dosage and Administration (2.1) ]. Closely monitor patients for hypersensitivity and infusion-related reactions during each TRODELVY infusion and for at least 30 minutes after completion of each infusion [see Dosage and Administration (2.3) ] . Permanently discontinue TRODELVY for Grade 4 infusion-related reactions [see Dosage and Administration (2.4) ] . 5.4 Nausea and Vomiting TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 63% of all patients treated with TRODELVY. Grade 3-4 nausea occurred in 3% of patients. Vomiting occurred in 33% of all patients treated with TRODELVY. Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK 1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV) [ see Dosage and Administration (2.1) ]. Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting at the time of scheduled treatment administration and resume with additional supportive measures when resolved to ≤Grade 1 [see Dosage and Administration (2.4) ]. 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. 5.5 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 when treated with TRODELVY. The incidence of neutropenia and anemia was analyzed in 1202 patients who received TRODELVY and had UGT1A1 genotype results. In patients homozygous for the UGT1A1 *28 allele (n=138), the incidence of Grade 3-4 neutropenia was 57%. In patients heterozygous for the UGT1A1*28 allele (n=531), the incidence of Grade 3-4 neutropenia was 48%. In patients homozygous for the wild-type allele (n=533), the incidence of Grade 3-4 neutropenia was 41% [see Clinical Pharmacology (12.5) ] . In patients homozygous for the UGT1A1 *28 allele, the incidence of Grade 3-4 anemia was 17%. In patients heterozygous for the UGT1A1*28 allele, the incidence of Grade 3-4 anemia was 9%. In patients homozygous for the wild-type allele, the incidence of Grade 3-4 anemia was 8%. The median time to first neutropenia including febrile neutropenia was 9 days in patients homozygous for the UGT1A1*28 allele, 19 days in patients heterozygous for the UGT1A1*28 allele, and 21 days in patients homozygous for the wild-type allele. The median time to first anemia was 22 days in patients homozygous for the UGT1A1*28 allele, 29 days in patients heterozygous for the UGT1A1*28 allele, and 29 days 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 enzyme activity [see Dosage and Administration (2.4) ]. 5.6 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 [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1) ]. 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 [see Use in Specific Populations (8.1 , 8.3) ] .

7 DRUG INTERACTIONS UGT1A1 Inhibitors or Inducers : Avoid concomitant use. ( 7 ) 7.1 Effect of Other Drugs on TRODELVY 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 [see Warnings and Precaution (5.5) and Clinical Pharmacology (12.3 , 12.5) ] . UGT1A1 Inducers Avoid administering UGT1A1 inducers with TRODELVY. SN-38 is a UGT1A1 substrate. Concomitant administration of TRODELVY with inducers of UGT1A1may reduce exposure to SN-38 [see Warnings and Precaution (5.5) and Clinical Pharmacology (12.3 , 12.5) ] .

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Neutropenia [see Warnings and Precautions (5.1) ] Diarrhea [see Warnings and Precautions (5.2) ] Hypersensitivity and Infusion-Related Reactions [see Warnings and Precautions (5.3) ] Nausea and Vomiting [see Warnings and Precautions (5.4) ] The most common adverse reactions including laboratory abnormalities: TRODELVY as a single agent (incidence ≥ 25%) were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, nausea, diarrhea, decreased lymphocyte count, fatigue, alopecia, increased glucose, constipation, vomiting, decreased albumin, increased alkaline phosphatase, decreased appetite, abdominal pain, decreased creatinine clearance, decreased magnesium, and decreased potassium. ( 6.1 ) TRODELVY in combination with pembrolizumab (incidence ≥25%) were decreased neutrophil count, decreased hemoglobin, decreased leukocyte count, diarrhea, nausea, decreased lymphocyte count, fatigue, alopecia, increased alkaline phosphatase, increased glucose, increased alanine aminotransferase, constipation, increased aspartate aminotransferase, rash, decreased potassium, increased lactate dehydrogenase, vomiting, abdominal pain, headache, increased eosinophils, and decreased albumin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-888-983-4668 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The pooled safety population described in the Warnings and Precautions section reflect exposure to TRODELVY as a single agent in 1354 patients, which included 641 patients with mTNBC and 322 patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer from ASCENT-03, IMMU-132-01, ASCENT, and TROPiCS-02; and 391 patients with other tumor types. TRODELVY was administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles at doses of 10 mg/kg until disease progression or unacceptable toxicity. Among the 1354 patients treated with TRODELVY, the median duration of treatment was 4.9 months (range: 0 to 63 months). In this pooled safety population, 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 (26%), and decreased potassium (26%). The data described in the following section reflects exposure to TRODELVY in combination with intravenous pembrolizumab in 221 patients with PD-L1 positive TNBC from ASCENT-04. Among the 221 patients who received TRODELVY in combination with intravenous pembrolizumab, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased neutrophil count and decreased hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and increased 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, increased eosinophils (26% each) and decreased albumin (25%). Locally Advanced or Metastatic Triple-Negative Breast Cancer (TNBC) Single-Agent in Previously Untreated Unresectable Locally Advanced or Metastatic TNBC (ASCENT-03) The safety of TRODELVY was evaluated in 275 patients with unresectable locally advanced or metastatic TNBC who had not received previous systemic therapy for advanced disease and who were not candidates for PD-1 or PD-L1 inhibitor therapy who had received at least one dose of TRODELVY 10 mg/kg in ASCENT-03. [see Clinical Studies (14.1) ] . The median duration of treatment was 8.3 months (range: 0 to 29 months). Serious adverse reactions occurred in 26% of patients receiving TRODELVY. Serious adverse reactions in > 2% of patients included diarrhea, febrile neutropenia, and neutropenia (3.6% each) and pneumonia (2.9%). Fatal adverse reactions occurred in 2.5% of patients who received TRODELVY including sepsis (1.1%) and acute respiratory failure , neutropenic colitis, pneumonia, and septic shock (0.4% each). Permanent discontinuation of TRODELVY due to adverse reactions occurred in 3.6% of patients, of which interstitial lung disease accounted for 1.1%. Dosage interruptions of TRODELVY occurred in 66% of patients. Adverse reactions which required dosage interruption in ≥ 5% of patients were decreased neutrophil count (43%), diarrhea (6%), decreased leukocyte count and COVID-19 (5% each). Dose reductions of TRODELVY due to an adverse reaction occurred in 37% of patients. Adverse reaction which required dose reductions in >2% of patients included decreased neutrophil count (18%), diarrhea (6%), fatigue (4.7%), febrile neutropenia (2.5%), and weight decreased (2.2%). The most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count (84%), decreased leukocyte count (80%), decreased hemoglobin (78%), nausea (61%), diarrhea and alopecia (55% each), increased glucose (52%), decreased lymphocyte count and fatigue (47% each), increased alanine aminotransferase (39%), increased alkaline phosphatase and constipation (38% each), increased lactate dehydrogenase (35%), increased aspartate aminotransferase (31%), decreased potassium (28%) and vomiting (25%). Tables 3 and 4 summarize the adverse reactions and laboratory abnormalities in ASCENT-03. Table 3: Adverse Reactions in ≥ 10% of Patients with Metastatic TNBC in ASCENT-03 TRODELVY (n=275) Treatment of Physician’s Choice Treatment of Physician’s Choice included gemcitabine/carboplatin (n=122), nab-paclitaxel (n=110), and paclitaxel (n=44) (n=276) Adverse Reaction Graded per NCI CTCAE v.5.0. All Grades (%) Grade 3 - 4 (%) All Grades (%) Grade 3 - 4 (%) Gastrointestinal disorders Nausea 61 1.8 34 0.4 Diarrhea Includes other related terms 55 10 20 0.7 Constipation 38 0 25 0 Vomiting 25 1.8 13 1.4 Abdominal Pain 24 0.7 12 0 Stomatitis 19 1.1 9 0.4 Skin and subcutaneous tissue disorders Alopecia 55 0 27 0 Rash 20 0.4 18 0.4 Pruritus 10 0 6 0 General disorders and administration site conditions Fatigue 47 3.3 47 4.0 Edema 11 0.4 11 0 Pyrexia 11 1.1 10 0.7 Respiratory, thoracic and mediastinal disorders Cough 18 0 13 0.4 Metabolism and nutrition disorders Decreased appetite 17 0.7 10 0.4 Nervous system disorders Headache 17 0.4 12 0 Peripheral neuropathy 12 0 31 0.4 Infections and infestations Upper respiratory tract infection 16 0.4 9 0 Urinary tract infection 10 0.7 15 0.7 Musculoskeletal and connective tissue disorders Arthralgia 15 0 17 0.4 Back pain 11 0.4 8 0.4 Table 4: Laboratory Abnormalities in > 10% of Patients with Metastatic TNBC in ASCENT-03 Laboratory Abnormality TRODELVY (n=275) Treatment of Physician’s Choice (n=276) All Grades (%) Grade 3 - 4 (%) All Grades (%) Grade 3 - 4 (%) Hematology Decreased neutrophil count 84 47 80 43 Decreased leukocyte count 80 29 80 33 Decreased hemoglobin 78 7 81 19 Decreased lymphocyte count 47 16 53 19 Decreased platelet count 18 6 40 17 Chemistry Increased glucose 52 0 44 0 Increased alanine aminotransferase 39 4.0 56 6 Increased alkaline phosphatase 38 1.1 35 0 Increased lactate dehydrogenase 35 0 35 0 Increased aspartate aminotransferase 31 2.2 47 2.5 Decreased potassium 28 5 18 2.5 Decreased albumin 23 2.5 14 0.4 Decreased magnesium 19 2.9 25 0.7 Decreased sodium 18 1.5 15 1.1 Increased phosphate 16 0 9 0 Increased potassium 16 0.7 18 0.7 Increased magnesium 14 5 11 1.8 Hypoglycemia 14 1.1 9 0 Decreased phosphate 12 0 10 0 Increased urate 12 0 4 0 In Combination with Pembrolizumab in Previously Untreated, Unresectable Locally Advanced or Metastatic TNBC whose tumors express PD-L1 (ASCENT-04) The safety of TRODELVY in combination with pembrolizumab was evaluated in 221 patients with unresectable locally advanced or metastatic TNBC who have not received previous systemic therapy for advanced disease and whose tumors express PD-L1 who received at least one dose of TRODELVY 10 mg/kg in combination with pembrolizumab. [see Clinical Studies (14.1) ] . The median duration of treatment of TRODELVY was 8.9 months (range: 0 to 27 months ). Serious adverse reactions occurred in 38% of patients receiving TRODELVY in combination with pembrolizumab. Serious adverse reactions in ≥ 2% of patients included febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), fatigue and pneumonia (2.3% each). Fatal adverse reactions occurred in 3.2% of patients who received TRODELVY in combination with pembrolizumab including death (unknown cause) (0.9%) and completed suicide, neutropenic sepsis, sepsis, pneumonia, and pulmonary embolism (0.5% each). Permanent discontinuation of TRODELVY due to an adverse reaction occurred in 7% of patients. Adverse reactions which resulted in permanent discontinuation of TRODELVY in ≥1% of patients included infusion related reaction (0.9%). Dosage interruptions of TRODELVY due to an adverse reaction occurred in 75% of patients. Adverse reactions which required dosage interruption in ≥5% of patients included neutropenia (44%), upper respiratory tract infection (10%), diarrhea (8%), COVID-19 (6%), and anemia and fatigue (5% each). Dose reduction of TRODELVY due to an adverse reaction occurred in 35% of patients. Adverse reactions which required dose reductions in ≥5% of patients included neutropenia (15%), diarrhea (8%), and fatigue (6%). G-CSF was used in 63% of patients who received TRODELVY in combination with pembrolizumab. The most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased neutrophil count and decreased hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and increased 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%). Tables 5 and 6 summarize the adverse reactions and laboratory abnormalities in ASCENT-04. Table 5: Adverse Reactions in ≥ 10% of Patients Receiving TRODELVY in Combination with Intravenous Pembrolizumab with Metastatic TNBC in ASCENT-04 TRODELVY plus pembrolizumab N=221 Treatment of Physician’s Choice Treatment of Physician’s Choice included gemcitabine/carboplatin (n=107), nab-paclitaxel (n=68), and paclitaxel (n=45) plus pembrolizumab N=220 Adverse Reactions Graded per NCI CTCAE v. 5.0 All Grades (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%) Gastrointestinal disorders Diarrhea Includes other related terms 72 12 30 2.7 Nausea 68 3.2 38 1.8 Constipation 41 0.5 35 0.5 Vomiting 29 0.9 14 1.8 Abdominal Pain 26 0.5 15 0 Stomatitis 18 0.5 16 0 General disorders and administration site conditions Fatigue 58 8 56 3.2 Edema 16 0.5 17 0.5 Pyrexia 12 0.9 12 0.5 Skin and subcutaneous tissue disorders Alopecia 52 0 32 0 Rash 37 1.4 33 1.8 Pruritus 14 0.5 12 0.9 Nervous system disorders Headache 26 0.5 18 0 Peripheral neuropathy 13 0.9 39 4.5 Dizziness 12 0 10 0 Musculoskeletal and connective tissue disorders Arthralgia 19 0.9 24 0.5 Respiratory, thoracic and mediastinal disorders Cough 19 0.5 20 0 Metabolism and nutrition disorders Decreased appetite 18 1.8 14 0 Hypothyroidism 11 0.5 18 0 Infections and infestations Upper respiratory tract infection 18 0 13 0 Urinary tract infection 16 1.4 16 0.5 COVID-19 10 0.5 7 0.5 Reproductive system and breast disorders Breast pain 10 0 9 0 Investigations Weight decreased 10 0 5 0.5 Table 6: Laboratory Abnormalities in > 10% of Patients Receiving TRODELVY in Combination with Intravenous Pembrolizumab with Metastatic TNBC in ASCENT-04 Laboratory Abnormality TRODELVY plus pembrolizumab N=221 TPC plus pembrolizumab N=220 All Grades (%) Grade 3 - 4 (%) All Grades (%) Grade 3 - 4 (%) Hematology Decreased neutrophil count 86 50 86 47 Decreased hemoglobin 86 10 88 18 Decreased leukocytes count 84 32 83 31 Decreased lymphocyte count 61 21 60 19 Increased eosinophils 26 0 17 0 Decreased platelet count 16 5 43 17 Chemistry Increased alkaline phosphate 50 0.9 33 1.8 Increased glucose 50 0 47 0 Increased alanine aminotransferase 47 4.1 55 8 Increased aspartate aminotransferase 40 3.7 51 4.1 Decreased potassium 35 4.6 24 2.3 Increased lactate dehydrogenase 34 0 37 0 Decreased albumin 25 0.9 14 0.9 Decreased sodium 20 1.4 20 3.2 Increased Urate 19 0 7 0 Increased magnesium 17 6 13 3.7 Increased phosphate 17 0 12 0 Decreased magnesium 16 1.4 21 0 Increased thyroid stimulating hormone 15 0 24 0 Decreased phosphate 14 0 9 0 Increased blood bilirubin 12 3.7 8 3.2 Increased sodium 12 0.5 2.3 0.5 Decreased glucose 11 0 15 1.4 Increased potassium 11 0.9 9 0.9 Previously Treated Locally Advanced or Metastatic TNBC (ASCENT) The safety of TRODELVY was evaluated in 258 patients with metastatic TNBC who had previously received a taxane and at least two prior chemotherapies and who received at least one dose of TRODELVY 10 mg/kg in ASCENT. [see Clinical Studies (14.1) ] . The median duration of treatment was 4.4 months (range: 0 to 23 months). Serious adverse reactions occurred in 27% of patients receiving TRODELVY. Serious adverse reactions in > 1% of patients receiving TRODELVY included neutropenia (7%), diarrhea (4%), and pneumonia (3%). Fatal adverse reactions occurred in 1.2% of patients who received TRODELVY, including respiratory failure (0.8%) and pneumonia (0.4%). Permanent discontinuation of TRODELVY due to an adverse reaction occurred in 5% of patients. Adverse reactions which resulted in permanent discontinuation of TRODELVY in ≥1% of patients included pneumonia and fatigue (1% each). Dosage interruptions of TRODELVY due to an adverse reaction occurred in 63% of patients. Adverse reactions which required dosage interruption in ≥5% of patients included neutropenia (47%), diarrhea (5%), respiratory infection (5%), and leukopenia (5%). Dose reductions of TRODELVY due to an adverse reaction occurred in 22% of patients. Adverse reactions which required a dose reduction in >4% of patients included neutropenia (11%) and diarrhea (5%). Granulocyte-colony stimulating factor (G-CSF) was used in 44% of patients who received TRODELVY. The most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (94%), decreased lymphocyte count (88%), decrease leukocyte count (86%), decreased neutrophil count (78%), fatigue (65%), diarrhea (59%), nausea (57%), increased glucose (49%), alopecia (47%), constipation (37%), decreased calcium (36%), vomiting, decreased magnesium, and decreased potassium (33% each), increased albumin (32%), abdominal pain (30%), decreased appetite (28%), increased aspartate aminotransferase (27%), increased alanine aminotransferase, increased alkaline phosphatase and decreased phosphate (26% each). Tables 7 and 8 summarize adverse reactions and laboratory abnormalities, respectively, in ASCENT. Table 7: Adverse Reactions in ≥ 10% of Patients with Metastatic TNBC in ASCENT TRODELVY (n=258) Single Agent Chemotherapy Single agent chemotherapy included one of the following single-agents: eribulin (n=139), capecitabine (n=33), gemcitabine (n=38), or vinorelbine (except if patient had ≥ Grade 2 neuropathy, n=52). (n=224) Adverse Reaction All Grades % Grade 3 - 4 % All Grades % Grade 3 - 4 % i. Graded per NCI CTCAE v.5.0. General disorders and administration site conditions Fatigue Includes other related terms 65 6 50 9 Pyrexia 15 0.4 14 2.2 Gastrointestinal disorders Diarrhea 59 11 17 0.9 Nausea 57 3.1 26 0.4 Vomiting 33 1.6 16 1.3 Constipation 37 0.4 23 0 Abdominal Pain 30 2.7 12 1.3 Stomatitis 17 1.6 13 1.3 Skin and subcutaneous tissue disorders Alopecia 47 0 16 0 Rash 12 0.4 5 0.4 Pruritus 10 0 3.1 0 Metabolism and nutrition disorders Decreased appetite 28 1.6 21 0.9 Respiratory, thoracic and mediastinal disorders Cough 24 0 18 0.4 Nervous system disorders Headache 18 0.8 13 0.4 Dizziness 10 0 7 0 Musculoskeletal and connective tissue disorders Back pain 16 1.2 14 1.8 Arthralgia 12 0.4 7 0 Infections and infestations Urinary tract infection 13 0.4 8 0.4 Upper respiratory tract infection 12 0 3.1 0 Psychiatric disorders Insomnia 11 0 5 0 Table 8: Laboratory Abnormalities in > 10% of Patients with Metastatic TNBC in ASCENT Laboratory Abnormality TRODELVY (n=258) Single Agent Chemotherapy (n=224) All Grades (%) Grade 3 - 4 (%) All Grades (%) Grade 3 - 4 (%) Hematology Decreased hemoglobin 94 9 57 6 Decreased lymphocyte count 88 31 40 24 Decreased leukocyte count 86 41 53 25 Decreased neutrophil count 78 49 48 36 Decreased platelet count 23 1.2 25 2.7 Chemistry Increased glucose 49 2.3 43 2.8 Decreased calcium 36 1.6 21 1.4 Decreased magnesium 33 0.4 20 0 Decreased potassium 33 4.3 28 0.9 Increased albumin 32 0.8 25 1.4 Increased aspartate aminotransferase 27 1.2 32 1.4 Increased alanine aminotransferase 26 1.2 26 1.8 Increased alkaline phosphatase 26 0 17 0.5 Decreased phosphate 26 7.8 20 3.3 Decreased sodium 22 0.4 17 0.5 Increased lactate dehydrogenase 18 0 22 0 Decreased glucose 10 0 3.2 0 Study IMMU-132-01 The safety of TRODELVY was evaluated in 108 patients with metastatic TNBC who had received at least two prior anticancer therapies for metastatic disease who received at least one dose of TRODELVY at doses up to 10 mg/kg. [see Clinical Studies (14.1) ] . The median duration of treatment was 5.1 months (range: 0 to 51 months). Serious adverse reactions occurred in 31% of patients receiving TRODELVY. Serious adverse reactions in > 1% of patients receiving TRODELVY included febrile neutropenia (6%) vomiting (5%), diarrhea (3.7%), nausea and dyspnea (2.8%), anemia, pleural effusion, neutropenia, pneumonia, dehydration (each 1.9%). A fatal adverse reaction of metastases to spine occurred in 1 patient (0.9%) who received TRODELVY. Permanent discontinuation of TRODELVY due to an adverse reaction occurred in 2.8% of patients. Adverse reactions which resulted in permanent discontinuation of TRODELVY included anaphylaxis, decreased appetite, fatigue, and localized edema (each 0.9%). Dosage interruptions of TRODELVY due to an adverse reaction occurred in 45% of patients. Adverse reactions which required dosage interruption in ≥2% of patients included neutropenia (33%), leukocytes decreased (6%), febrile neutropenia (3.7%), and anemia (2.8%). Dose reductions of TRODELVY due to an adverse reaction occurred in 33% of patients. Adverse reactions which required dose reductions most commonly included neutropenia/febrile neutropenia. The most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (93%), decreased leukocyte count (91%), decreased neutrophil count (82%), nausea (69%), diarrhea (63%), increased activated partial thromboplastin time (60%), fatigue and increased alkaline phosphatase (57% each), vomiting and decreased calcium (49% each), increased aspartate aminotransferase (45%), decreased albumin (39%), alopecia (38%), increased alanine aminotransferase (35%), constipation (34%), rash and increased glucose (31% each), decreased appetite and decreased platelet count (30% each), decreased phosphate (29%), decreased magnesium (27%), abdominal pain (26%), respiratory infection (26%), and decreased sodium (25%). Tables 9 and 10 summarize adverse reactions and laboratory abnormalities occurring in ≥10% of patients with metastatic TNBC in Study IMMU-132-01. Table 9: Adverse Reactions in ≥ 10% of Patients with Metastatic TNBC in IMMU-132-01 Adverse Reaction TRODELVY (n=108) All Grades (%) Grade 3-4 (%) i. Graded per NCI CTCAE v. 4.0 Any adverse reaction 100 71 Gastrointestinal disorders 95 21 Nausea 69 6 Diarrhea 63 9 Vomiting 49 6 Constipation 34 0.9 Abdominal pain Includes other related terms 26 0.9 Mucositis 14 0.9 General disorders and administration site conditions 77 9 Fatigue 57 8 Edema 19 0 Pyrexia 14 0 Metabolism and nutrition disorders 68 22 Decreased appetite 30 0.9 Dehydration 13 5 Skin and subcutaneous tissue disorders 63 3.7 Alopecia 38 0 Rash 31 2.8 Pruritus 17 0 Dry Skin 15 0 Nervous system disorders 56 3.7 Headache 23 0.9 Dizziness 22 0 Neuropathy 24 0 Dysgeusia 11 0 Infections and infestations 55 12 Respiratory Infection 26 2.8 Urinary Tract Infection 21 2.8 Musculoskeletal and connective tissue disorders 54 0.9 Back pain 23 0 Arthralgia 17 0 Pain in extremity 11 0 Respiratory, thoracic and mediastinal disorders 54 5 Cough 22 0 Dyspnea 21 2.8 Psychiatric disorders 26 0.9 Insomnia 13 0 Table 10: Laboratory Abnormalities observed in > 10% of Patients with Metastatic TNBC in IMMU-132-01 Laboratory Abnormality TRODELVY (n=108) All Grades (%) Grade 3-4 (%) Hematology Decreased hemoglobin 93 6 Decreased leukocyte count 91 26 Decreased neutrophil count 82 32 Increased activated partial thromboplastin time 60 12 Decreased platelet count 30 2.8 Chemistry Increased alkaline phosphatase 57 1.9 Decreased calcium 49 2.8 Increased aspartate aminotransferase 45 2.8 Decreased albumin 39 0.9 Increased alanine aminotransferase 35 1.9 Increased glucose 31 2.8 Decreased phosphate 29 5 Decreased magnesium 27 1.9 Decreased sodium 25 4.7 Decreased potassium 24 3.7 Decreased glucose 19 1.9 Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer TROPiCS-02 The safety of TRODELVY was evaluated in 268 patients with unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer whose disease has progressed after the following in any setting: a CDK 4/6 inhibitor, endocrine therapy, and a taxane; patients received at least two prior chemotherapies in the metastatic setting (one of which could be in the neoadjuvant or adjuvant setting if progression occurred within 12 months) who had received at least one dose of TRODELVY 10 mg/kg in TROPiCS-02. [see Clinical Studies (14.2) ] . The median duration of treatment was 4.1 months (range: 0 to 63 months). Serious adverse reactions occurred in 28% of patients who received TRODELVY. Serious adverse reactions in >1% included diarrhea (5%), febrile neutropenia (4.1%), neutropenia (3.0%), abdominal pain (2.2%), neutropenic colitis , and vomiting (1.9 each%), and colitis and pneumonia 1.5% each). Fatal adverse reactions occurred in 2.2% of patients who received TRODELVY including arrhythmia, COVID-19 pneumonia, pneumonia, nervous system disorder, pulmonary embolism, and septic shock (0.4% each). Permanent discontinuation of TRODELVY due to an adverse reaction occurred in 6% of patients. Adverse reactions which resulted in permanent discontinuation of TRODELVY in ≥ 0.5% of patients included asthenia, general physical health deterioration, and neutropenia (0.7% each). Dosage interruptions of TRODELVY due to an adverse reaction occurred in 66% of patients. Adverse reactions which required dosage interruption in ≥ 5% of patients included neutropenia (50%). Dose reductions of TRODELVY due to an adverse reaction occurred in 33% of patients. Adverse reactions which required dose reductions in >5% of patients included neutropenia (16%) and diarrhea (8%). G-CSF was used in 54% of patients who received TRODELVY. The most common (≥ 25%) adverse reactions, including laboratory abnormalities, were decreased leukocyte count (88%), decreased neutrophil count (83%), decreased hemoglobin (73%), decreased lymphocyte count (65%), diarrhea (62%), fatigue (60%), nausea (59%), alopecia (48%), increased glucose (37%), constipation (34%), and decreased albumin (32%). Tables 11 and 12 summarize adverse reactions and laboratory abnormalities in TROPiCS-02. Table 11: Adverse Reactions in ≥ 10% of Patients with Metastatic HR+/HER2- Breast Cancer in TROPiCS-02 TRODELVY (n=268) Single Agent Chemotherapy Single agent chemotherapy included one of the following single-agents: eribulin (n=130), vinorelbine (n=63), gemcitabine (n=56), or capecitabine (n=22). (n=249) Adverse Reaction Graded per NCI CTCAE V 5.0 All Grades % Grade 3 - 4 % All Grades % Grade 3 - 4 % Gastrointestinal disorders Diarrhea 62 10 23 1.2 Nausea 59 1.1 35 2.8 Constipation 34 0.4 25 0 Vomiting 23 1.1 16 1.6 Abdominal Pain 20 3.7 14 0.8 Dyspepsia Includes other related terms 11 0 6 0 General disorders and administration site conditions Fatigue 60 8 51 4.4 Skin and subcutaneous tissue disorders Alopecia 48 0 19 0 Pruritus 12 0.4 2.4 0 Metabolism and nutrition disorders Decreased appetite 21 1.5 21 0.8 Hypokalemia 10 1.5 3.6 0.4 Respiratory, thoracic and mediastinal disorders Dyspnea 20 0 17 0 Cough 12 0 7 0.4 Musculoskeletal and connective tissue disorders Arthralgia 15 0.7 12 0.4 Nervous system disorders Headache 16 0.4 15 0.4 Other clinically significant adverse reactions in TROPiCS-02 (≤ 10%) include: hypotension, pain, and rhinorrhea (4.9% each), hypocalcemia (3.0%), nasal congestion (2.6%), skin hyperpigmentation, (2.6%), colitis or neutropenic colitis (2.2%), pneumonia (1.9%), proteinuria (1.1%), enteritis (0.4%). Table 12: Laboratory Abnormalities in > 10% of Patients with Metastatic HR+/HER2- Breast Cancer in TROPiCS-02 Laboratory Abnormality TRODELVY (n=268) Single Agent Chemotherapy (n=249) All Grades (%) Grade 3 - 4 (%) All Grades (%) Grade 3 - 4 (%) Hematology Decreased leukocyte count 88 38 73 26 Decreased neutrophil count 83 53 67 40 Decreased hemoglobin 73 8 59 5 Decreased lymphocyte count 65 21 47 14 Decreased platelet count 21 1.1 30 3.7 Eosinophilia 13 0 4.1 0 Chemistry Increased glucose 37 0 31 0 Decreased albumin 32 0 27 0.4 Decreased creatinine clearance 24 2.3 19 1.3 Increased alkaline phosphatase 23 0 23 0.8 Decreased potassium 22 3.4 12 0.4 Increased alanine aminotransferase 21 1.1 31 2.1 Decreased sodium 19 0.8 17 0.4 Decreased magnesium 18 0 15 0 Decreased phosphate 17 0 10 0 Increased phosphate 16 0 16 0 Increased lactate dehydrogenase 16 0 28 0 Increased aspartate aminotransferase 15 1.5 25 1.3 Increased potassium 14 1.9 9 0

8.1 Pregnancy Risk Summary Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. TRODELVY contains a genotoxic component, SN-38, and is toxic to rapidly dividing cells [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1) ] . Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively. Data Animal data There were no reproductive and developmental toxicology studies conducted with sacituzumab govitecan-hziy.