Epratuzumab is under clinical development by Gilead Sciences and currently in the Phase III 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 Epratuzumab’s likelihood of approval (LoA) and phase transition for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia) took place on 22 Jun 2021, 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 Epratuzumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Epratuzumab overview

Epratuzumab (Lymphocide, IMMU103, IMMU-hLL2) is under development for the treatment of pediatric and adult B-cell or T-cell acute lymphoblastic leukemia (ALL). The therapeutic candidate is administered through subcutaneous and intravenous route. It is a murine LL2 antibody which is subsequently re-engineered into the humanized (hLL2) form. The therapeutic candidate is based on DOCK-and-LOCK method, or DNL platform technology. It was also under development for the treatment of systemic lupus erythematosus (SLE), Waldenstrom macroglobulinemia, diffuse large b-cell lymphoma, Sjogren's syndrome, non-hodgkin lymphoma and follicular lymphoma and acute lymphocytic leukemia.

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 Epratuzumab LOA Data

Report Segments
  • Innovator
Drug Name
  • Epratuzumab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Immunology
  • Oncology
Key Developers
Highest Development Stage
  • Phase III

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.