Trodelvy® (sacituzumab govitecan-hziy)
Washout Period Prior to Starting Treatment

Trodelvy® (sacituzumab govitecan-hziy)

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 Clinical Studies

ASCENT Study in mTNBC2

In ASCENT, a phase 3 study 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- mBC3

In TROPiCS-02, a phase 3 study in 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).

TROPHY-U-01 Study in Metastatic Urothelial Cancer4

In TROPHY-U-01, a phase 2 study in metastatic urothelial cancer, eligible patients were required to have a washout period of ≥4 weeks from a prior anti-cancer monoclonal antibody and ≥2 weeks beyond prior treatment chemotherapy, targeted small molecule therapy, and/or radiation therapy. Patients were required to have a washout period of ≥2 weeks from high-dose systemic corticosteroids. However, low doses of corticosteroids equivalent to 20mg of prednisone daily or less were allowed for reasons outside of central nervous system, disease as long as the dose was stable for 4 weeks. Additionally, all acute toxicities were required to have recovered to Grade ≤1, except for alopecia and neuropathy, for which Grade ≤2 was allowed.

IMMU-132-01 Study in Metastatic Epithelial Cancers5

In IMMU-132-01, a phase 1/2 study in patients with previously treated advanced epithelial cancers (including patients with metastatic triple-negative breast cancer [mTNBC], hormone receptor-positive/human epidermal growth factor 2 receptor-negative metastatic breast cancer [HR+/HER2- mBC], and metastatic urothelial cancer [mUC]), 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. 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.
3. 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.
4. Tagawa ST, Balar AV, Petrylak DP, et al. TROPHY-U-01: A phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors [Protocol]. J Clin Oncol. 2021;39(22):2474-2485.
5. 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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