Daratumumab is under clinical development by Johnson & Johnson and currently in the Phase I and Phase II 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 Daratumumab’s likelihood of approval (LoA) and phase transition for Amyloidosis took place on 26 Dec 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.

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

Daratumumab overview

Daratumumab ((HuMax-CD38, JNJ-54767414, Darzalex, Dalinvi) is an immunoglobulin G1 kappa (IgG1κ) human monoclonal antibody against CD38 antigen, produced in a mammalian cell line. It is formulated as solution and concentrate solution for intravenous route of administration. Daratumumab is indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. Darzalex is indicated in combination with lenalidomide and dexamethasone, or bortezomib and  dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy, and in combination with bortezomib, melphalan and prednisone (VMP), for the treatment of patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplantation, in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients who are ineligible for autologous stem  cell  transplant, and in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). It is also indicated in combination with carfilzomib and dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy and also indicated in combination with bortezomib, cyclophosphamide, and dexamethasone, for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.

Daratumumab is under development for treatment of precursor B-cell lymphoblastic leukemia-lymphoma, T-cell leukemia, peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), relapsed or refractory plasmablastic lymphoma, POEMS syndrome, metastatic renal cell carcinoma or muscle invasive bladder cancer, triple negative breast cancer, plasma cell leukemia, pancreatic adenocarcinnoma rheumatoid arthritis, chronic lymphocytic leukemia, amyloid light-chain (AL) amyloidosis as a first line therapy, front line multiple myeloma, T-cell acute lymphoblastic leukemia, lymphoblastic lymphoma relapsed and refractory natural killer/T-cell lymphomas (NKTCL), myelodysplastic syndrome and relapsed or refractory acute myelogenous leukemia, acute lymphoblastic leukemia, systemic lupus erythematosus, lupus nephritis and waldenstrom macroglobulinemia. It is developed using  recombinant DNA technology. It is a new molecular entity (NME). It was also under development for the treatment of relapsed or refractory B-cell non-Hodgkin lymphomas including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, prostate cancer as first-line therapy, and non-small cell lung cancer

Johnson & Johnson overview

Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products, medical devices, and consumer products. The company provides pharmaceuticals for immune diseases, cancer, neurological disorders, infectious, cardiovascular and metabolic diseases; consumer products in oral care, baby care, beauty, over-the-counter (OTC) medicines, women’s health and wound care categories; and medical devices for use in the cardiovascular, orthopaedic, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, health care professionals and hospitals; and offers consumer products through retail outlets and distributors. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US). J&J is headquartered in New Brunswick, New Jersey, the US.

Quick View Daratumumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Daratumumab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Immunology
  • Metabolic Disorders
  • Oncology
Key Developers
  • Sponsor Company: Johnson & Johnson
  • Originator: Genmab
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.