National Stroke Foundation

Imbruvica (ibrutinib)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved January 2017

Specific Treatments:

marginal zone lymphoma

Therapeutic Areas

General Information

Imbruvica (ibrutinib) is an orally available, selective inhibitor of Bruton's tyrosine kinase (Btk).

Imbruvica is specifically indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. 

Imbruvica is supplied as a capsule or tablet for oral administration. The recommended dose of Imbruvica for MZL is 560 mg orally once daily until disease progression or unacceptable toxicity.  

Clinical Results

FDA Approval

The FDA approval of Imbruvica for MZL was based on a phase 2, open-label, multi-center, single-arm study, which evaluated the safety and efficacy of Imbruvica in MZL patients who require systemic therapy and have received at least one prior anti-CD20-based therapy. The efficacy analysis included 63 patients. The ORR was achieved in nearly half (46%) of the patients as assessed by an Independent Review Committee (IRC) using criteria adopted from the International Working Group criteria for malignant lymphoma. The median time to response was 4.5 months. In the trial, 3.2% of patients had a complete response (CR) and 42.9% of patients had a partial response (PR). The median duration of responses was not reached (NR) (range 16.7 months to NR).

Side Effects

Adverse effects associated with the use of Imbruvica may include, but are not limited to, the following:

neutropenia

thrombocytopenia

diarrhea

anemia

musculoskeletal pain

rash

nausea

bruising

fatigue

hemorrhage

pyrexia

Mechanism of Action

Imbruvica (ibrutinib) is an orally available, selective inhibitor of Bruton's tyrosine kinase (Btk). Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK’s crole in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion.

Additional Information

For additional information regarding Imbruvica or marginal zone lymphoma please visit https://www.imbruvica.com/