Trodelvy® (sacituzumab govitecan-hziy)

Use in Older Patients With mBC

This document is in response to your request for information regarding the use of Trodelvy® (sacituzumab govitecan-hziy [SG]) in older patients (defined as ≥65 years of age) with metastatic breast cancer (mBC).

Some data may be outside of the US FDA-approved prescribing information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA-approved prescribing information.

The full indication, important safety information, and boxed warnings for neutropenia and diarrhea are available at:

www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.

Summary

Relevant Product Labeling1

SG is indicated for the treatment of adult patients with unresectable locally advanced or mTNBC who have received ≥2 prior systemic therapies, ≥1 of them for metastatic disease.

• Of the 366 patients with TNBC who were treated with SG, 19% of patients were ≥65 years and 3% were ≥75 years. Patients ≥65 had an increased incidence of neutropenia, including fatal outcomes. No other differences in safety and effectiveness were observed between patients ≥65 years of age and younger patients.

SG is indicated for the treatment of adult patients with unresectable locally advanced or metastatic HR+, HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and ≥2 additional systemic therapies in the metastatic setting.

• Of the 322 patients with HR+/HER2- breast cancer who were treated with SG, 26% of patients were ≥65 years and 6% were ≥75 years. No overall differences in effectiveness were observed between patients ≥65 years of age and younger patients. There was a higher discontinuation rate due to adverse reactions in patients aged ≥65 years (14%) compared with younger patients (3%).

SG Clinical Data in Older Patients With mBC

Post hoc subgroup analyses of patients <65 y and ≥65 y, treated with SG 10 mg/kg IV on Days 1 and 8 of a 21-day cycle (unless noted otherwise) as monotherapy and in combination with pembro are summarized.

Clinical Data of SG Monotherapy

Results from ASCENT, a study in 2L+ mTNBC,2 showed that regardless of age, mPFS and mOS numerically favored SG vs TPC.3

• mPFS (HR [95% CI]) for SG and TPC, respectively, was 7.1 vs 2.4 mo (0.246 [0.141–0.428]) in patients ≥65 y (n=101), 4.2 vs 1.6 mo (0.45 [0.353–0.573]) in patients <65 y (n=428), and 4.8 vs 1.7 mo (0.414 [0.333–0.516]) in the ITT population (N=529). mOS (HR [95% CI]) for SG and TPC, respectively was 14.7 vs 8.9 mo (0.467 [0.292–0.749]) in patients ≥65 y, 10.8 vs 6.7 mo (0.535 [0.433–0.622]) in patients <65 y, and 11.8 vs 6.9 mo (0.526 [0.433–0.637]) in the ITT population.2,3

• Older patients in the SG arm had a slightly higher rate of Grade ≥3 TEAEs vs TPC (69 vs 63%). Patients ≥65 y experienced higher rates of TEAEs that led to dose reduction vs patients <65 y (37 vs 19%). The incidence of TEAEs leading to SG treatment discontinuation was 2% in older patients and 5% in the OSP and patients <65 y.3 In older patients treated with SG vs TPC, the most common Grade ≥3 TEAEs were neutropenia (47 vs 40%) and anemia (14 vs 6%). Grade ≥3 diarrhea was reported by 12% of patients receiving SG, there were no reported cases with TPC.3,4

Results of a predefined subgroup analysis from ASCENT-03, an ongoing study in 1L PD-(L)1 inhibitor ineligible mTNBC, showed that mPFS numerically favored SG vs TPC; mPFS (HR [95% CI]) for SG vs TPC, respectively, was 11.1 vs 9 mo (0.91 [0.58–1.44]) in patients ≥65 y (n=143), 9.6 vs 5.7 mo (0.58 [0.45–0.74]) in patients <65 y (n=415), and 9.7 vs 6.9 mo (0.66 [0.53–0.82]) in the ITT population (N=558). Results for OS were immature at the time of the analysis. Safety has not been presented for subgroups.5

Results from TROPiCS-02, a study in pretreated HR+/HER2- mBC,6 showed that regardless of age, mPFS and mOS numerically favored SG vs TPC.7,8

• mPFS (HR [95% CI]) for SG vs TPC, respectively, was 6.7 vs 3.5 mo (0.59 [0.38–0.93]) in patients ≥65 y (n=140), 5.5 vs 4.1 mo (0.69 [0.53–0.89]) in patients <65 y (n=403), and 5.5 vs 4 mo (0.66 [0.53–0.82]) in the ITT population (N=543). mPFS (HR [95% CI]) in patients ≥65 y with an SG RDI >90% was 6.7 vs 5.5 mo for SG RDIs ≤74 and >74 to ≤90%. mOS (HR [95% CI]) in the SG and TPC arms, respectively was 14.9 vs 10.1 mo (0.8 [0.54–1.19]) in patients ≥65 y, 14.1 vs 11.5 mo (0.81 [0.64–1.02]) in patients <65 y, and 14.4 vs 11.2 mo (0.79 [0.65–0.96]) in the ITT population.6,8,9
• Older patients in the SG arm had more TEAEs that led to dose reduction and treatment discontinuation vs TPC; 38 vs 28% and 17 vs 5%, respectively. TEAEs within the older SG subgroup led to dose reduction and treatment discontinuation more commonly vs the <65 y subgroup; 38 vs 32% and 17 vs 3%, respectively. Rates of Grade ≥3 TEAEs were similar across age subgroups but occurred at higher rates in patients treated with SG vs TPC; 73 vs 60% and 75 vs 61% in patients <65 and ≥65 y, respectively. In older patients treated with SG vs TPC, the most common Grade ≥3 TEAEs were neutropenia (44 vs 36%) and diarrhea (17 vs 2%).8

ASCENT-07, an ongoing study in 1L post-ET HR+/HER2- mBC, did not meet its primary endpoint of PFS. Results of a predefined subgroup analysis showed that mPFS numerically favored SG vs TPC regardless of age. mPFS (HR [95% CI]) for SG vs TPC, respectively, was 9.7 vs 9.4 mo (0.88 [0.59–1.30]) in patients    ≥65 y (n=180), 8.3 vs 8.2 mo (0.87 [0.68–1.1]) in patients <65 y (n=510), and 8.3 vs 8.3 mo (0.88 [0.72–1.08]) in the ITT population (N=690). OS results were immature at the time of the analysis. Safety has not been presented for subgroups.10

Clinical Data of SG in Combination With Pembro

Results of a predefined subgroup analysis from ASCENT-04, an ongoing study in 1L PD-L1+ mTNBC, showed that mPFS numerically favored SG vs TPC. mPFS (HR [95% CI]) for SG vs TPC, respectively, was 11.1 vs 9.3 mo (0.85 [0.52–1.39]) in patients ≥65 y (n=115), 11.3 vs 7.5 mo (0.61 [0.45–0.82]) in patients <65 y (n=328), and 11.2 vs 7.8 mo (0.66 [0.51–0.85]) in the ITT population (N=443). OS results were immature at the time of the analysis. Safety has not been presented for subgroups.11,12

Real World Data of SG in Older Patients With mBC

A retrospective mTNBC study (N=303), across 18 oncology centers in Poland, the Czech Republic and Slovakia reported outcomes for SG as monotherapy. mPFS (HR [95% CI]) for patients >65 vs ≤65 y, respectively, was 5.42 vs 4.07 mo (0.716 [0.534–0.960], P=0.026); mOS (HR [95% CI]) was 12.81 vs 10.91 mo (0.691 [0.485–0.985], P=0.041) respectively. AE-related dose reductions occurred in 46.1% of patients >65 y and 34.8% of patients ≤65 y (P =0.106).13,14

SG Clinical Data in Older Patients With mBC

Post hoc subgroup analyses of patients <65 y and ≥65 y, treated with SG 10 mg/kg IV on Days 1 and 8 of a 21-day cycle (unless noted otherwise) as monotherapy and combination therapy are summarized. The primary endpoint across all SG clinical studies in mBC was mPFS by BICR per RECIST v1.1.

Clinical Data of SG Monotherapy

ASCENT Study in 2L+ mTNBC

An open‑label, randomized, phase 3 study, compared the efficacy and safety of SG (n=267) vs TPC (n=262; eribulin, vinorelbine, capecitabine, or gemcitabine) in patients with refractory or relapsed mTNBC who had received ≥2 prior chemotherapies for unresectable, locally advanced, or metastatic disease. The primary endpoint was mPFS in patients without brain metastasis. In the ITT population, mPFS was 4.8 vs 1.7 mo (HR 0.43; 95% CI 0.35–0.54), and mOS was 11.8 vs 6.9 mo (HR 0.51; 95% CI 0.41–0.62) with SG and TPC, respectively.2

Post Hoc Subgroup Analysis in Patients <65 and ≥65 Years

Approximately 19% of patients were ≥65 y, of these, 8 and 13 patients in the SG and TPC arms respectively, were ≥75 y. Most older patients vs patients <65 y were female (99 vs >99%) and White (85 vs 78%).3,15 See Table 1 for select baseline demographics and characteristics.

Table 1. ASCENT: Select Baseline Demographics and Characteristics3

aRefers to any prior metastatic/neoadjuvant/locally advanced regimens used to treat an eligible breast cancer patient. Prior therapy in the adjuvant setting is excluded from this count.

In general, disease characteristics were similar between patients <65 y and ≥65 y with some exceptions. Patients <65 y with known BRCA 1/2 status had a higher rate (61%) of negative germline BRCA mutations vs patients ≥65 y (35%). Generally, the most common prior regimens were used at higher frequencies in patients <65 vs ≥65 y, including anthracyclines (86 vs 67%, respectively) and cyclophosphamide (85 vs 73%), prior checkpoint inhibitors (30 vs 23%), and neoadjuvant systemic therapies (53 vs 24%).3

Efficacy results3

SG improved outcomes vs TPC in older patients. See Table 2 for outcomes by age.

Table 2. ASCENT: Efficacy in Patients <65 and ≥65 Years3

Safety results

Within the OSP, patients who received ≥1 dose of study drug (n=482), older patients in the SG arm had a slightly higher rate of Grade ≥3 TEAEs vs TPC. Patients ≥65 y were more likely to undergo dose reduction due to TEAEs vs patients <65 y. The incidence of TEAEs leading to SG treatment discontinuation was 2% in older patients and 5% in the OSP. See Table 3 for further TEAEs in the OSP and in patients <65 and ≥65 y.3

Table 3. ASCENT: Safety Summary of the OSP and Patients <65 and ≥65 Years3

In the OSP, the most common any grade TEAEs, in both treatment arms, included diarrhea (65%), neutropenia (64%), nausea (62%), and fatigue (52%). These were the most common any grade TEAEs in older patients; all occurred at a higher frequency with SG than TPC. The most common Grade ≥3 TEAEs for SG in the OSP were neutropenia (52%) and diarrhea (11%); these were the most common Grade ≥3 TEAEs in patients ≥65 y and occurred at a higher frequency than with TPC (Table 4).3

Table 4. ASCENT: TEAEs in Patients <65 and ≥65 Years4

aAny grade and Grade ≥3 TEAEs occurring in ≥36% and ≥8% of patients treated with SG in either subgroup.

bGrade ≥3 AE not reported in ≥5% of patients in the SG arm or TPC arm.

ASCENT-03 Study in 1L PD-(L)1 inhibitor ineligible mTNBC5

An ongoing, global, open-label, randomized, phase 3 study, compares the efficacy and safety of SG vs TPC (gemcitabine + carboplatin, paclitaxel, or nab‑paclitaxel), as 1L treatment in patients with previously untreated, locally advanced, inoperable or mTNBC who are not candidates for PD-(L)1 inhibitor therapy. See Table 5 for select baseline demographics and characteristics.

Table 5. ASCENT-03: Select Baseline Demographics and Disease Characteristics5

In the ITT population, mPFS (95% CI) was 9.7 (8.1–11.1) vs 6.9 (5.6–8.2) mo (stratified HR 0.62 [95% CI 0.5–0.77] P<0.001) with SG and TPC, respectively; see Table 6 for results of a predefined subgroup analysis for PFS in older and younger patients. OS results were immature at the time of the primary analysis.

Table 6. ASCENT-03: Subgroup Analysis of PFS in Patients <65 and ≥65 Years5

TROPiCS-02 Study in Pretreated HR+/HER2- mBC

An open-label, randomized, multicenter, phase 3 study, compared the efficacy and safety of SG (n=272) vs TPC (n=271; eribulin, vinorelbine, gemcitabine, capecitabine) in patients with HR+/HER2- mBC who were previously treated with ≥1 taxane, ≥1 endocrine therapy, and ≥1 CDK4/6i in any setting, and who had received ≥2 and ≤4 prior chemotherapy regimens for metastatic disease.6

In the ITT population, mPFS was 5.5 (4.2–7) vs 4 (3.1–4.4) mo (HR, 0.66; 95% CI 0.53–0.83; P=0.0003)6 and mOS was 14.4 (13–15.7) vs 11.2 (10.1–12.7) mo (HR, 0.79; 95% CI 0.65–0.96; P=0.02) for SG and TPC, respectively.9

Post Hoc Subgroup analysis

Safety and efficacy was assessed in patients <65 vs ≥65 y8 and <75 vs ≥75 y7; ≈26% (n=140) were ≥65 y, of those, 24 were ≥75 y. Most older patients were female (SG, 100%; TPC, 99%) and White (SG, 68%; TPC, 64% [race was not reported in 41 older patients]). Baseline characteristics were generally similar across treatments. A higher proportion of patients had an ECOG PS of 1 vs 0 in the ≥65 vs <65 y (Table 7) and the ≥75 vs <75 y subgroups, respectively.7,8

Table 7. TROPiCS-02: Select Demographics and Baseline Characteristics in Patients <65 and ≥65 Years8

aUse was unknown in 7 patients <65 y and in 1 patient ≥65 y.

Efficacy results

Regardless of age, mPFS and mOS numerically favored SG vs TPC (Table 8).7,8

Table 8. TROPiCS-02: Efficacy According to Age Subgroup7,8

aPer BICR. bRefers to patients <65 and ≥65 y. cRefers to patients <75 and ≥75 y.

mPFS was numerically higher in older patients with an RDI (cumulative SG dose divided by total planned SG dose) of >90 vs ≤74% and >74 to ≤90% (Table 9).8

Table 9. TROPiCS-02: Efficacy by RDI in Patients <65 and ≥65 Years8

SG had a longer TTD for fatigue in patients <65 y (Table 10) vs TPC. SG was also numerically favored vs TPC for median TTD for global health status/QoL in patients <65 and ≥65 y, and for median TTD for pain in patients ≥65 y.8

Table 10. TROPiCS-02: TTD of QoL in Patients <65 and ≥65 Years8

Safety results

Patients ≥65 y treated with SG, experienced more TEAEs that led to dose reduction and treatment discontinuation vs patients ≥65 y treated with TPC. TEAEs in the SG arm that led to dose reduction and treatment discontinuation were more common in patients ≥65 vs those <65 y. Grade ≥3 TEAEs and TEAEs that led to treatment interruptions occurred at higher rates in patients treated with SG vs TPC, and the rates of these TEAEs were similar across age subgroups (Table 11 and Table 12).8 In the ≥75 y subgroup, Grade ≥3 TEAEs were more common vs other subgroups, as were TEAEs that led to dose reductions, however, the small sample size for this subgroup limits interpretation.7

Table 11. TROPiCS-02: TEAEs According to Age Subgroup7,8

Table 12. TROPiCS-02: Most Common TEAEs in Patients <65 and ≥65 Years8

TEAEs occurring in ≥30% of patients in either treatment arm within either age subgroup.

ASCENT-07 Study in 1L Post-ET in HR+/HER2- mBC10

An ongoing, global, randomized, open-label, phase 3 study, compares the efficacy and safety of SG vs TPC (capecitabine, paclitaxel, or nab-paclitaxel) in patients with HR+/HER2- (IHC 0, IHC 1+, IHC 2+/ISH-) locally advanced, inoperable, or mBC who have received prior ET and are candidates for first chemotherapy. See Table 13 for select demographics and characteristics, including prior therapies.

Table 13. ASCENT-07: Select Baseline Demographics and Disease Characteristics10

aTherapies reported are not mutually exclusive.

bOther targeted therapies in the SG and TPC groups included everolimus (25 and 22%), alpelisib (5 and 3%), and olaparib (2 and 3%).

cSome patients had unknown adjuvant therapy history.

The study did not meet its primary endpoint; mPFS (95% CI) in the ITT population was 8.3

mo (8.1–10.3) for SG vs 8.3 mo (6.9–10) for TPC; HR 0.85 (95% CI 0.69–1.05), P=0.13.

See Table 14 for results of a predefined subgroup analysis of PFS in older and younger

patients. OS results were immature at the time of the primary analysis.

Table 14. ASCENT-07: Subgroup Analysis of PFS in Patients <65 and ≥65 Years10

Clinical Data of SG in Combination With Pembro

ASCENT-04 Study in 1L PD-L1+ mTNBC

An ongoing, global, open-label, randomized, phase 3 study, is comparing the efficacy and safety of SG + pembro vs TPC (gemcitabine + carboplatin, paclitaxel, or nab-paclitaxel) + pembro, as 1L treatment in patients with PD-L1+ (CPS ≥10), inoperable, locally advanced or mTNBC. See Table 15 for select demographics and characteristics.

Table 15. ASCENT-04: Select Baseline Demographics and Disease Characteristics12

aWhile 20 patients were included in the stratified subgroup of prior exposure to anti-PD-(L)1 therapy (yes) per the interactive response technology system, only 6 patients received prior treatment with anti-PD-(L)1 agents per the clinical database (3 in each treatment group).

In the ITT population, SG + pembro prolonged mPFS (95% CI) vs TPC + pembro (11.2 vs 7.8 mo; stratified HR, 0.65; 95% CI: 0.51–0.84; P<0.001). See Table 16 for results of a predefined subgroup analysis for PFS in older vs younger patients. OS results were immature at the time of the primary analysis.

Table 16. ASCENT-04: Subgroup Analysis of PFS in Patients <65 and ≥65 Years12

Abbreviation: NR=not reached.

Real-World Data of SG in Older Patients

A retrospective, real-world study (N=303), across 18 oncology centers in Poland, the Czech Republic and Slovakia reviewed outcomes for SG as monotherapy in older vs younger women with mTNBC. A total of 25.1% were older patients; see Table 17 for select demographics and characteristics.13,14

Table 17. Select Baseline Demographics and Disease Characteristics13,14

A reduced starting dose of SG ≤8 mg/kg at cycle 1 day 1 was administered in 13.2 and 7.5% of older and younger patients, respectively (P=0.204).14 The median number of full SG cycles was similar across age groups (P=0.240).13 See Table 18 for results of efficacy outcomes.

Table 18. Efficacy Outcomes in Patients ≤65 and >65 Years13,14

Abbreviation: mDOR=median duration of response.

AE-related dose reductions occurred in 46.1% of patients >65 y and 34.8% of patients ≤65 y (P =0.106).14

1. TRODELVY® Gilead Sciences Inc. Trodelvy (sacituzumab govitecan-hziy) for injection, for intravenous use. U.S. Prescribing Information. Foster City, CA.

2. Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384(16):1529-1541.

3. Hurvitz SA, Bardia A, Punie K, et al. Subgroup analyses from the phase 3 ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. NPJ Breast Cancer. 2024;10(1):33.

4. Hurvitz SA, Bardia A, Punie K, et al. Subgroup analyses from the phase 3 ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer [Supplementary Appendix]. NPJ Breast Cancer. 2024;10(1):33.

5. 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.

6. Rugo HS, Bardia A, Marme F, et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022;40(29):3365-3376.

7. Bardia A, Schmid P, Tolaney S, et al. Efficacy and clinical outcomes by age subgroups in the phase 3 TROPiCS-02 study of sacituzumab govitecan vs treatment of physician’s choice in HR+/HER2‒ metastatic breast cancer [Abstract 1578376]. Presented at: San Antonio Breast Cancer symposium (SABCS); December 5-9, 2023; San Antonio, TX.

8. Bardia A, Schmid P, Tolaney S, et al. Clinical outcomes by age subgroups in the phase 3 TROPiCS-02 study of sacituzumab govitecan vs treatment of physician’s choice in HR+/HER2‒ metastatic breast cancer [Poster PO5-21-09]. Presented at: San Antonio Breast Cancer symposium (SABCS); December 5-9, 2023; San Antonio, TX.

9. Rugo HS, Bardia A, Marmé F, et al. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023;S0140-6736(23):01245-X.

10. Jhaveri K, Park YH, Barrios C, et al. Sacituzumab govitecan vs chemotherapy as first therapy after endocrine therapy in HR+/HER2- (IHC 0, 1+, 2+/ISH-) metastatic breast cancer: primary results from ASCENT-07. Presented at: San Antonio Breast Cancer Symposium (SABCS); December 9-12, 2025; San Antonio, TX.

11. Tolaney SM, De Azambuja E, Kalinsky K, et al. Sacituzumab govitecan plus pembrolizumab vs chemotherapy plus pembrolizumab in patients with previously untreated, PD-L1-positive, advanced or metastatic triple-negative breast cancer: primary results from the randomized, Phase 3 ASCENT-04/KEYNOTE-D19 study [Oral]. Presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; 30 May-03 June, 2025; Chicago, IL.

12. Tolaney S, De Azambuja E, Kalinsky K, et al. Sacituzumab govitecan plus pembrolizumab for advanced triple-negative breast cancer. N Engl J Med. 2026;394:354-366.

13. Konieczna A, Holanek M, Pieniazek M, et al. Treatment patterns and outcomes of sacituzumab govitecan in older versus younger patients with mTNBC: multinational real-world data [Poster: PS5-02-20]. Presented at: San Antonio Breast Cancer Symposium (SABCS); 09-12 December 2025; San Antonio, Texas.

14. Konieczna A, Holanek M, Pieniazek M, et al. Treatment patterns and outcomes of sacituzumab govitecan in older versus younger patients with mTNBC: multinational real-world data [Abstract: PS5-02-20]. Presented at: San Antonio Breast Cancer Symposium (SABCS); 09-12 December 2025; San Antonio, Texas.

15. Rugo HS, Tolaney SM, Loirat D, et al. Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer. NPJ Breast Cancer. 2022;98(8).

AE=adverse event
BICR=blinded independent central review
BRCA=breast cancer gene
CDK4/6i=cyclin-dependent kinase 4/6 inhibitor
CPS=combined positive score
ECOG PS=Eastern Cooperative Oncology Group performance status
ET=endocrine therapy
HR=hazard ratio
HR+/HER2-=hormone receptor-positive/human epidermal growth factor receptor 2-negative
mBC=metastatic breast cancer
mOS=median overall survival
mPFS=median progression-free survival
mTNBC=metastatic triple-negative breast cancer
NE=not estimable
NR=not reported
ORR=objective response rate
OSP=overall safety population
PD-L1+=programmed death ligand 1-positive
PD-(L)1=programmed death (ligand) 1
pembro=pembrolizumab
QoL=quality of life
RDI=relative dose intensity
SG=sacituzumab govitecan-hziy
TEAE=treatment-emergent adverse event
TPC=treatment of physician’s choice
TTD=time to deterioration
 

Product Label

For the full indication, important safety information, and boxed warning(s), please refer to the Trodelvy US Prescribing Information available at:
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