TRODELVY

(Sacituzumab Govitecan)

Phase 3Antibody–drug conjugate

Gilead

TRODELVY is one of 33 biologic programs targeting Small Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Small Cell CarcinomaRecruiting

Metastatic Triple-Negative Breast CancerRecruiting

Extensive Stage Small Cell Lung Cancer (ES-SCLC)Recruiting

Anatomic Stage IV Breast Cancer AJCC V8Recruiting

Metastatic HER2-Negative Breast CarcinomaRecruiting

Metastatic Bladder Urothelial CarcinomaActive, not recruiting

Locally Advanced Urothelial CarcinomaRecruiting

Recurrent Platinum-Sensitive Fallopian Tube Endometrioid AdenocarcinomaNot yet recruiting

HRD CancerActive, not recruiting

Small Cell CarcinomaPhase 2

Recruiting

Metastatic Triple-Negative Breast CancerPreclinical

Recruiting

Extensive Stage Small Cell Lung Cancer (ES-SCLC)Phase 3

Recruiting

Anatomic Stage IV Breast Cancer AJCC V8Phase 2

Recruiting

Metastatic HER2-Negative Breast CarcinomaPhase 2

Recruiting

Metastatic Bladder Urothelial CarcinomaPhase 3

Active, not recruiting

Locally Advanced Urothelial CarcinomaPhase 3

Recruiting

Recurrent Platinum-Sensitive Fallopian Tube Endometrioid AdenocarcinomaPhase 2

Not yet recruiting

HRD CancerPreclinical

Active, not recruiting

Competition

Competitive Landscape

19 competitors in Small Cell Carcinoma

#DrugCompanyPhaseTrials

TRODELVY

Gilead

Phase 3

1 2

Imfinzi

AstraZeneca

Phase 2

1 3

Tecentriq

Roche

Phase 2

1 4

Zepzelca

Jazz Pharmaceuticals

Phase 2

1 5

Adstiladrin

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Phase 2

1 6

Vepesid

AAvyxa

Phase 2

1 7

Bavencio

EMD Serono

Phase 2

1 8

Paraplatin

AAvyxa

Phase 2

1 9

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 2

1 10

Tarceva

DDutch Society of Physicians for Pulmonology and Tuberculosis

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Anatomic Stage IV Breast Cancer AJCC V8

NCT03606967

Q4 2028

Phase 2Recruiting

Metastatic HER2-Negative Breast Carcinoma

NCT05770531

Phase 2Recruiting

Small Cell Carcinoma

NCT06161532

Phase 3Recruiting

Locally Advanced Urothelial Carcinoma

NCT06524544

Q1 2029

PreclinicalActive, not recruiting

HRD Cancer

NCT04826341

Q2 2029

Phase 2Not yet recruiting

Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma

NCT07504588

Clinical

Trials by Indication[1]

Anatomic Stage IV Breast Cancer AJCC v81 trial

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03606967·86 enrolled

Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma1 trial

A Randomized Phase II Trial of Sacituzumab Govitecan (SG) and Bevacizumab Versus Standard of Care Carboplatin, Pegylated Liposomal Doxorubicin (PLD) and Bevacizumab in Patients With Platinum-Sensitive Ovarian Cancer That Has Progressed on Prior Maintenance PARP Inhibitor Therapy

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07504588·87 enrolled

Metastatic Triple-negative Breast Cancer1 trial

Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT07011654·31 enrolled

HRD Cancer1 trial

A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04826341·35 enrolled

Small Cell Carcinoma1 trial

A Phase II Study of Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06161532·60 enrolled

4 more indications

Metastatic Bladder Urothelial Carcinoma1 trial

A Phase III Randomized Trial of Eribulin (NSC #707389) With Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT04579224·184 enrolled

Locally Advanced Urothelial Carcinoma1 trial

A Phase III Randomized Trial of Pembrolizumab in Combination With Sacituzumab Govitean-hziy vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer

Recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT06524544·320 enrolled

Extensive Stage Small Cell Lung Cancer (ES-SCLC)1 trial

A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Recruiting· Gilead logo

Gilead·Phase 3·NCT06801834·695 enrolled

Metastatic HER2-Negative Breast Carcinoma1 trial

A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer

Recruiting·VVanderbilt-Ingram Cancer Center·Phase 2·NCT05770531·160 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 22, 2020

TRODELVY

BLA BLA761115

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Sacituzumab Govitecan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sacituzumab Govitecan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sacituzumab Govitecan. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761115). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Antibody–drug conjugate[2]
Highest Phase: Phase 3[1]
Company: Gilead

TRODELVY

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2028

Q1 2029

Q2 2029

Trials by Indication[1]

Anatomic Stage IV Breast Cancer AJCC v81 trial

Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma1 trial

Metastatic Triple-negative Breast Cancer1 trial

HRD Cancer1 trial

Small Cell Carcinoma1 trial

Metastatic Bladder Urothelial Carcinoma1 trial

Locally Advanced Urothelial Carcinoma1 trial

Extensive Stage Small Cell Lung Cancer (ES-SCLC)1 trial

Metastatic HER2-Negative Breast Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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