Sacituzumab govitecan is under clinical development by Gilead Sciences and currently in the Phase II, Phase III and Pre-Registration in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Sacituzumab govitecan’s likelihood of approval (LoA) and phase transition for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer) took place on 13 Oct 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Sacituzumab govitecan Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Sacituzumab govitecan overview

Sacituzumab govitecan (Trodelvy) is a conjugated humanized monoclonal antibody with potential antineoplastic activity. It is formulated as lyophilized powder for solution for intravenous route of administration. Trodelvy is indicated for the treatment of adult patients with unresectable or locally advanced metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Sacituzumab govitecan (IMMU-132) is under development for the treatment of advanced or metastatic urothelial carcinoma, papillary thyroid cancer, hepatocellular carcinoma, refractory or relapsed advanced including epithelial ovarian cancer, colorectal, gastric, hepatocellular, bladder cancer, head and neck squamous cell carcinoma, metastatic hormone-refractory prostate, small-cell and metastatic non-small-cell lung cancer, pancreatic ductal adenocarcinoma, HER2 negative breast cancer, esophageal, renal cell cancer, metastatic transitional (Urothelial) tract cancer, endometrial cancer, cervical cancer, esophageal squamous cell carcinoma (escc), glioblastoma multiforme malignant glioma, muscle invasive bladder cancer and metastatic breast cancer with brain metastasis. It is administered as an intravenous route. IMMU-132 is a camptothecin-based ADC where the antibody, RS7 is attached to SN38. IMMU-132 targets cells expressing TROP-2. It was also under development for follicular thyroid cancer and adenocarcinoma.

Gilead Sciences overview

Gilead Sciences (Gilead) is a research-based biopharmaceutical company. It is engaged in the discovery, development and commercialization of medicines for the treatment of cardiovascular, hematological and respiratory diseases, inflammation, liver diseases, cancer and human immunodeficiency virus (HIV) infection. The company sells its products through subsidiaries and distributors in Europe, the Americas, Asia-Pacific, the Middle East and Africa. It has manufacturing facilities in Edmonton, Alberta, Canada; Foster City, San Dimas, Oceanside, California; and Cork, Ireland among others. The company has partnerships with universities, medical research institutions and global pharmaceutical leaders to develop new drugs. Gilead is headquartered in Foster City, California, the US.

Quick View Sacituzumab govitecan LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Sacituzumab govitecan
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.