Daratumumab by Johnson & Johnson for Lymphoblastic Lymphoma: Likelihood of Approval

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Daratumumab overview

Daratumumab ((HuMax-CD38, JNJ-54767414, Darzalex, Dalinvi, Darzalex Faspro) 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 (primary systemic 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) and acute lymphoblastic leukemia, systemic lupus erythematosus, lupus nephritis, primary antiphospholipid syndrome and pancreatic ductal adenocarcinoma. 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

It was also under development for the treatment of waldenstrom macroglobulinemia and relapsed or refractory acute myelogenous leukemia, myelodysplastic syndrome.

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, neurovascular care, 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.

For a complete picture of Daratumumab’s drug-specific PTSR and LoA scores, buy the report here.

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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.