Trodelvy® (sacituzumab govitecan)

Washout Period Prior to Starting Treatment

This document is in response to your request for information about a washout period prior to starting treatment with Trodelvy® (sacituzumab govitecan-hziy [SG]).

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

Relevant Product Labeling1

There is no recommendation of a washout period described in the SG Prescribing Information.

Washout Periods in SG Clinical Studies

ASCENT-04 Study in First-Line PD-L1+ mTNBC

ASCENT-04 is an ongoing, phase 3 study of SG plus pembrolizumab in patients with previously untreated, locally advanced unresectable or programmed cell death ligand-1 positive metastatic triple-negative breast cancer (mTNBC). In this study, eligible patients were required to have a washout period from other previous systemic anticancer treatment (with the exception of endocrine therapy) of ≥6 months and from radiation therapy of ≥2 weeks prior to enrollment.2 Additionally, all acute toxicities due to previously administered agents were required to have resolved to Grade ≤1. Exceptions to recovery requirements included endocrine-related toxicities and peripheral neuropathy, which could be Grade ≤2 or alopecia of any-grade.3

ASCENT-03 Study in First-Line PD-(L)1 Inhibitor Ineligible mTNBC

ASCENT-03 is an ongoing, phase 3 study of SG in patients with previously untreated, locally advanced unresectable or mTNBC that are not candidates for programmed death-(ligand) 1 inhibitor therapy. In this study, eligible patients were required to have a washout period from other previous systemic anticancer treatment (with the exception of endocrine therapy) of ≥6 months and from radiation therapy of ≥2 weeks prior to enrollment.4 Additionally, all acute toxicities due to previously administered agents were required to have resolved to Grade ≤1. Exceptions to recovery requirements included endocrine-related toxicities and peripheral neuropathy, which could be Grade ≤2 or alopecia of any-grade.5

ASCENT Study in mTNBC6

In ASCENT, a phase 3 study of SG in patients with refractory/relapsed mTNBC, eligible patients were required to have a washout period ≥2 weeks from high-dose systemic corticosteroids and all prior cancer treatment, including chemotherapy, endocrine therapy, radiotherapy, and major surgery. Prior antibody treatment had to be completed ≥3 weeks before randomization. Patients who were receiving low-dose corticosteroids (≤20 mg prednisone daily or equivalent) were eligible as long as the dose was stable for 4 weeks. Individuals were not eligible for this study if they had an infection that required antibiotic use within 1 week of randomization. Additionally, all acute toxicities were required to have recovered to Grade ≤1. Exceptions to recovery requirements included alopecia and peripheral neuropathy, which could be Grade ≤2.

TROPiCS-02 Study in HR+/HER2- mBC7

In TROPiCS-02, a phase 3 study of SG in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (HR+/HER2- mBC), eligible patients were required to have a washout period of ≥2 weeks from prior chemotherapy, radiation, or small molecule targeted therapy and ≥4 weeks from biologic therapy. High-dose systemic corticosteroids were prohibited within 2 weeks of randomization. Low, stable doses of corticosteroids that were equivalent to ≤20 mg of prednisone daily were allowed if the patient entered the study on low‑dose steroids for their treated brain metastasis or if they were medically indicated as part of their infusion pre-medications. Topical steroids and corticosteroid inhalers were permitted. Additionally, all acute toxicities were required to have recovered to Grade ≤1 (except for alopecia and Grade 2 neuropathy).

IMMU-132-01 Study in Metastatic Epithelial Cancers8

In IMMU-132-01, a phase 1/2 study in patients with previously treated advanced epithelial cancers (including patients with mTNBC, HR+/HER2- mBC, and metastatic urothelial cancer), eligible patients were required to have a washout period ≥2 weeks from high dose systemic corticosteroids or prior treatment such as chemotherapy, immunotherapy, endocrine therapy, investigational drugs, and/or radiation therapy, or major surgery. Patients who were receiving low-dose corticosteroids (<20 mg prednisone daily or equivalent) were eligible. Individuals were not eligible for this study if they had an infection that required IV antibiotic use within one week of randomization. Additionally, all acute toxicities except for alopecia were required to have recovered to Grade ≤1.

References

1. TRODELVY® Gilead Sciences Inc. Trodelvy (sacituzumab govitecan-hziy) for injection, for intravenous use. U.S. Prescribing Information. Foster City, CA.
2. ClinicalTrials.gov. Study of sacituzumab govitecan-hziy and pembrolizumab versus treatment of physician's choice and pembrolizumab in patients with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer (ASCENT-04). ClinicalTrials.gov Identifier: NCT05382286. Available at: https://clinicaltrials.gov/ct2/show/NCT05382286. Accessed 25 June 2025. Last Updated: 24 December 2024.
3. Tolaney SM, De Azambuja E, Emens LA, et al. ASCENT-04/KEYNOTE-D19: phase 3 study of sacituzumab govitecan plus pembrolizumab vs treatment of physician’s choice plus pembro in first-line programmed death-ligand 1-positive metastatic triple-negative breast cancer [Poster 276TiP]. Presented at: European Society for Medical Oncology (ESMO) Congress; 9-13 September, 2022; Paris, France.
4. ClinicalTrials.gov. Study of sacituzumab govitecan-hziy versus treatment of physician's choice in patients with previously untreated locally advanced inoperable or metastatic triple-negative breast cancer (ASCENT-03), ClinicalTrials.gov Identifier: NCT05382299. Available at: https://clinicaltrials.gov/study/NCT05382299. Accessed 25 June 2025. Last Updated 18 May 2025.
5. Bardia A, Punie K, Barrios C, et al. ASCENT-03: Phase 3 study of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in first-line (1L) metastatic triple-negative breast cancer (mTNBC) [Poster 275TiP]. Paper presented at: European Society for Medical Oncology (ESMO) Congress 2022; 9-13 September, 2022; Paris, France.
6. Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer [Protocol]. N Engl J Med. 2021;384(16):1529-1541.
7. Rugo HS, Bardia A, Marme F, et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer [Protocol]. J Clin Oncol. 2022;40(29):3365-3376.
8. Immunomedics Inc. Protocol IMMU-132-01. A phase I/II study of IMMU-132 (hRS7-SN38 antibody drug conjugate) in patients with epithelial cancer. Available at: https://www.clinicaltrials.gov/ProvidedDocs/52/NCT01631552/Prot_000.pdf.

Product Label

For the full indication, important safety information, and Boxed Warning(s), please refer to the Trodelvy US Prescribing Information available at: https://www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.pdf.

Follow Up

For any additional questions, please contact Trodelvy Medical Information at:

☎1‐888-983-4668 or   www.askgileadmedical.com

Adverse Event Reporting

Please report all adverse events to:

Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
 https://www.gilead.com/utility/contact/report-an-adverse-event

FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or   www.accessdata.fda.gov/scripts/medwatch

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