Drug Profile

Ibrutinib - Janssen/Pharmacyclics

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

Latest Information Update: 26 Jun 2025

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At a glance

Originator Celera Genomics Group
Developer Bristol-Myers Squibb; Celgene Corporation; 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
Class 2 ring heterocyclic compounds; Antiallergics; 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; Mantle-cell lymphoma; Graft-versus-host disease
New Molecular Entity Yes

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; SARS-CoV-2 acute respiratory disease; Solid tumours; Squamous cell cancer; T-cell prolymphocytic leukaemia
Phase I/II Gastrointestinal cancer; Non-small cell lung cancer; Renal cell carcinoma; Urogenital cancer
No development reported Cancer; Colorectal cancer; Lymphoma; Myelodysplastic syndromes
Discontinued Breast cancer; Rheumatoid arthritis; Seasonal allergic rhinitis

20 Jun 2025 Preregistration for Mantle-cell lymphoma (Combination therapy, First-line therapy) in European Union (PO) prior to June 2025
20 Jun 2025 The CHMP recommends approval of ibrutinib for Mantle cell lymphoma (First-line therapy, Combination therapy) in the European Union
20 Jun 2025 Efficacy data from the phase III TRIANGLE trial in Mantle cell lymphoma released by Janssen

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