Isatuximab is under clinical development by Sanofi and currently in the Phase I, Phase II and 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 Isatuximab’s likelihood of approval (LoA) and phase transition for Epithelial Ovarian Cancer took place on 10 Jun 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

In addition, the same event on 10 Jun 2022 decreased Isatuximab’s LoA and PTSR for Hepatocellular Carcinoma, and decreased LoA and PTSR for Recurrent Glioblastoma Multiforme (GBM).

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

Isatuximab overview

Isatuximab (Sarclisa) is a monoclonal antibody acts as anticancer agent. It is formulated as solution and concentrate for solution for intravenous route of administration. Sarclisa is indicated for treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, and relapsed or refractory multiple myeloma.

Isatuximab (SAR650984) is under development for the treatment of relapsed or refractory natural killer cell lymphoma, T-cell lymphomas, amyloidosis, autoimmune hemolytic anemia, pediatric patients for the treatment of relapsed/refractory acute lymphoblastic leukemia and relapsed/refractory acute myeloid leukemia, as a second line therapy for hepatocellular carcinoma (HCC), recurrent glioblastoma multiforme (GBM) and epithelial ovarian cancer (EOC), hematological malignancies including B-cell non-Hodgkin-lymphoma/leukemia (NHL), acute myeloid leukemia (AML), metastatic colorectal cancer, chronic lymphocytic leukemia (CLL), plasma cell myeloma, smoldering multiple myeloma and relapsed and refractory multiple myeloma. It is administered through intravenous and subcutaneous routes. The drug candidate is a naked humanized monoclonal antibody targeting CD38 antigen. It is a new molecular entity (NME). It was also under development for the treatment of non-small cell lung cancer, metastatic castration-resistant prostate cancer, as a third line therapy for recurrent metastatic squamous cell carcinoma of the head and neck (SCCHN), T-cell acute lymphoblastic leukemia (T-ALL), diffuse large b-cell lymphoma, peripheral T-cell lymphoma, mantle cell lymphoma and acute lymphoblastic lymphoma.

It was also under development for the treatment of classic Hodgkin's lymphoma.

Sanofi overview

Sanofi is a healthcare company, which is engaged in the discovery, development, manufacturing and marketing of a wide range of medicines and vaccines. Its portfolio includes medicines for the treatment of cancer, diabetes, rare diseases, multiple sclerosis and cardiovascular diseases; human vaccines for protection against various bacterial and viral diseases; and other products. The company also offers consumer healthcare products for digestion; allergy; cough, cold, flu and sinus; pain; women’s health; and vitamins, minerals and supplements. Sanofi‘s R&D efforts focus on advancing a combination drugs to increase the effectiveness of treatments and on advancing the formulation of new biologics to produce precision medicines. It has operations in Europe, the Americas, Asia-Pacific, Africa and the Middle East. Sanofi is headquartered in Paris, France.

Quick View Isatuximab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Isatuximab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Hematological Disorders
  • Metabolic Disorders
  • Oncology
Key Developers
  • Sponsor Company: Sanofi
  • Originator: ImmunoGen
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.