Name

Ibrutinib

Alternate Names

Imbruvica
PCI-32765
RESONATE

Abbreviations

None

Category

Chemotherapy

Subcategory

Bruton tyrpsine kinase (Btk)

NSC Number

748645

Primary Site

B-cell malignancies
CLL
Mantle cell lymphoma
Multiple myeloma
NHL
Waldentrom macroglobulinemia (WM)
diffuese B-cell lymphoma
SLL

Histology

None

Remarks

The FDA has given ibrutinib the breakthrough therapy designation. The FDA has granted approval for this drug November 13, 2013. This drug is in additional clinical trials looking at its effect in combination with other agents in treatment of other types of leukemic and lymphoid malignancies.

March 4, 2016 The FDA has approved Imbruvica (ibrutinib) as first course treatment for patients with chronic lymphocytic leukemia.

August 4, 2017: FDA has approved ibrutinib (Imbruvica) for adult patients with chronic graft versus host disease after failure of one or more lines of systemic therapy, making it the first FDA-approved therapy for the treatment of cGVHD.

April 21, 2020 The FDA expanded the indication of ibrutinib (IMBRUVICA) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Coding

This drug should be coded
Glossary