MedPath

Ibrutinib

Generic Name
Ibrutinib
Brand Names
Imbruvica
Drug Type
Small Molecule
Chemical Formula
C25H24N6O2
CAS Number
936563-96-1
Unique Ingredient Identifier
1X70OSD4VX

Overview

Ibrutinib is a small molecule that acts as an irreversible potent inhibitor of Burton's tyrosine kinase. It is designated as a targeted covalent drug and presented as a promising activity in B-cell malignancies in clinical trials. Ibrutinib was developed by Pharmacyclics Inc and was first approved by the FDA in November 2013 for the treatment of mantle cell lymphoma (MCL) under accelerated approval; however, in April 2023, the drug manufacturer withdrew the accelerated approvals for ibrutinib in the US. Ibrutinib was approved by the EMA in October 2014 and by Health Canada in November 2014. It is currently approved for the treatment of various conditions, such as chronic lymphocytic leukemia (CLL), Waldenström's Macroglobulinemia, and chronic graft versus host disease (cGVHD) in August 2017. Notably, ibrutinib became the first FDA-approved cGVHD treatment for children in August 2017.

Background

Ibrutinib is a small molecule that acts as an irreversible potent inhibitor of Burton's tyrosine kinase. It is designated as a targeted covalent drug and presented as a promising activity in B-cell malignancies in clinical trials. Ibrutinib was developed by Pharmacyclics Inc and was first approved by the FDA in November 2013 for the treatment of mantle cell lymphoma (MCL) under accelerated approval; however, in April 2023, the drug manufacturer withdrew the accelerated approvals for ibrutinib in the US. Ibrutinib was approved by the EMA in October 2014 and by Health Canada in November 2014. It is currently approved for the treatment of various conditions, such as chronic lymphocytic leukemia (CLL), Waldenström's Macroglobulinemia, and chronic graft versus host disease (cGVHD) in August 2017. Notably, ibrutinib became the first FDA-approved cGVHD treatment for children in August 2017.

Indication

Ibrutinib is indicated for the treatment of the following conditions. Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) Waldenström's macroglobulinemia Chronic graft-versus-host disease (cGVHD) Mantle cell lymphoma (MCL) Marginal zone lymphoma (MZL)

Associated Conditions

  • Chronic Graft-Versus-Host Disease
  • Chronic Lymphocytic Leukemia
  • Marginal Zone Lymphoma (MZL)
  • Refractory Mantle Cell Lymphoma
  • Relapsed Mantle Cell Lymphoma
  • Small Lymphocytic Lymphoma
  • Steroid-dependent chronic graft-versus-host disease
  • Waldenström's Macroglobulinemia (WM)
  • Steroid refractory Chronic graft versus host disease

FDA Approved Products

Imbruvica
Manufacturer:Pharmacyclics LLC
Route:ORAL
Strength:420 mg in 1 1
Approved: 2024/02/29
NDC:57962-420
Imbruvica
Manufacturer:Pharmacyclics LLC
Route:ORAL
Strength:140 mg in 1 1
Approved: 2024/02/29
NDC:57962-140
Imbruvica
Manufacturer:Pharmacyclics LLC
Route:ORAL
Strength:560 mg in 1 1
Approved: 2024/02/29
NDC:57962-560
Imbruvica
Manufacturer:Pharmacyclics LLC
Route:ORAL
Strength:280 mg in 1 1
Approved: 2024/02/29
NDC:57962-280
Imbruvica
Manufacturer:Pharmacyclics LLC
Route:ORAL
Strength:70 mg in 1 mL
Approved: 2024/02/29
NDC:57962-007

Singapore Approved Products

IMBRUVICA FILM-COATED TABLETS 420MG
Manufacturer:Cilag AG (Bulk Production and Primary Packager), Janssen-Cilag SpA (Primary and Secondary Packager)
Form:TABLET, FILM COATED
Strength:420mg
Online:Yes
Approved: 2021/06/03
Approval:SIN16220P
IMBRUVICA FILM-COATED TABLETS 140MG
Manufacturer:Cilag AG (Bulk Production and Primary Packager), Janssen-Cilag SpA (Primary and Secondary Packager)
Form:TABLET, FILM COATED
Strength:140mg
Online:Yes
Approved: 2021/06/03
Approval:SIN16218P
IMBRUVICA FILM-COATED TABLETS 280MG
Manufacturer:Cilag AG (Bulk Production and Primary Packager), Janssen-Cilag SpA (Primary and Secondary Packager)
Form:TABLET, FILM COATED
Strength:280mg
Online:Yes
Approved: 2021/06/03
Approval:SIN16219P
IMBRUVICA FILM-COATED TABLETS 560MG
Manufacturer:Cilag AG (Bulk Production and Primary Packager), Janssen-Cilag SpA (Primary and Secondary Packager)
Form:TABLET, FILM COATED
Strength:560mg
Online:Yes
Approved: 2021/06/03
Approval:SIN16221P

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