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Ibrutinib - Janssen/Pharmacyclics

Drug Profile

Ibrutinib - Janssen/Pharmacyclics

Alternative Names: CRA-032765; IMBRUVICA; Imbruvica; ImBurvica; JNJ-54179060; PCI-32765

Latest Information Update: 14 Nov 2019

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At a glance

  • Originator Celera Genomics Group
  • Developer Foundation GIMEMA; Genentech; Janssen; Janssen Biotech; Lymphoma Academic Research Organisation; National Cancer Institute (USA); Northwestern University; OHSU Knight Cancer Institute; Pharmacyclics; Sheba Medical Center; Singapore General Hospital; Stanford University Medical Center; Thomas Jefferson University; University Hospital Muenster; University of California, Davis; University of California, San Diego; University of Leeds
  • Class 2 ring heterocyclic compounds; Antineoplastics; Antirheumatics; Phenyl ethers; Piperidines; Pyrazoles; Pyrimidines; Small molecules
  • Mechanism of Action Agammaglobulinaemia tyrosine kinase inhibitors; Emt protein-tyrosine kinase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Chronic lymphocytic leukaemia; Graft-versus-host disease
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chronic lymphocytic leukaemia; Graft-versus-host disease; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Waldenstrom's macroglobulinaemia
  • Phase III Diffuse large B cell lymphoma; Follicular lymphoma; Non-Hodgkin's lymphoma; Pancreatic cancer
  • Phase II Acute myeloid leukaemia; B-cell lymphoma; CNS cancer; Hairy cell leukaemia; Multiple myeloma; Precursor cell lymphoblastic leukaemia-lymphoma; Solid tumours; Squamous cell cancer; T-cell prolymphocytic leukaemia
  • Phase I/II Gastrointestinal cancer; Non-small cell lung cancer; Renal cell carcinoma; Urogenital cancer
  • Phase I Cancer; Myelodysplastic syndromes
  • Preclinical Colorectal cancer; Lymphoma
  • Discontinued Breast cancer; Rheumatoid arthritis; Seasonal allergic rhinitis

Most Recent Events

  • 08 Nov 2019 AbbVie files sNDA for treatment of patients with Chronic lymphocytic leukaemia (Combination therapy, First-line therapy) in USA (PO)
  • 08 Nov 2019 Registered for Chronic lymphocytic leukaemia (Combination therapy, Second-line therapy or greater) in Canada (PO)
  • 08 Nov 2019 Product Monograph of ibrutinib updated to include additional long-term efficacy data from the phase III RESONATE and RESONATE-2 trial
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