(Daratumumab + hyaluronidase (human recombinant)) is under clinical development by Johnson & Johnson and currently in Phase II for Alzheimer’s Disease. According to GlobalData, Phase II drugs for Alzheimer’s Disease have a 36% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how (Daratumumab + hyaluronidase (human recombinant))’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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 + hyaluronidase (human recombinant)) overview

Daratumumab and hyaluronidase-fihj (Darzalex Faspro, Darzalex, Darzquro, Dalinvi ) is a fixed dose combination act as antineoplastic agent developed based on halozyme's ENHANZE drug delivery technology. It is formulated as solution for subcutaneous route of administration. Darzalex Faspro is indicated for the treatment of adult patients with multiple myeloma in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant, for the treatment of adult patients with multiple myeloma in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, for the treatment of adult patients with multiple myeloma as monotherapy, in patients 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 proteasome inhibitor and an immunomodulatory agent, for the treatment of adult patients with multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. Darzalex Faspro is indicated for the treatment of adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. Darzalex Faspro in combination with bortezomib, cyclophosphamide and dexamethasone is indicated for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. Darzalex in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adults with multiple myeloma (MM) who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or after the last therapy. It is indicated in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.

Daratumumab in combination with hyaluronidase is under development for the treatment of newly diagnosed and transplant-ineligible patients, MGUS associated peripheral neuropathy, refractory and relapsed multiple myeloma and T-cell acute lymphoblastic leukemia.

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 + hyaluronidase (human recombinant))’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 7 February 2024

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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.