Regulatory Affairs

FDA approves Imbruvica for relapsed/refractory marginal zone lymphoma

Published 20 January 2017

The US Food and Drug Administration (FDA) has granted an accelerated approval to Imbruvica (ibrutinib) as first treatment specifically indicated for relapsed/refractory marginal zone lymphoma (MZL), a rare type of Non-Hodgkin's Lymphoma.

AbbVie company Pharmacyclics and Janssen Biotech are jointly developing and commercializing Imbruvica, which is oral, once-daily therapy that inhibits Bruton's tyrosine kinase (BTK) protein.

The approval in MZL is indicated for those who require systemic therapy and have received at least one prior anti-CD20-based therapy.

In the pivotal open-label phase 2 study, the objective response rates (ORR) with ibrutinib was 46%, with a complete response rate of 3.2%.

Imbruvica showed better response rates and duration of response in relapsed/refractory marginal zone lymphoma patients.

The most common adverse events (AEs) of all grades included thrombocytopenia (49%), fatigue (44%), anemia (43%), diarrhea (43%), bruising (41%), musculoskeletal pain (40%), hemorrhage (30%), rash (29%), nausea (25%), peripheral edema (24%), arthralgia (24%), neutropenia (22%), cough (22%), dyspnea (21%), and upper respiratory tract infection (21%).

The most common grade 3/4 AEs were decreases in hemoglobin (13%), neutrophil decrease (13%), and pneumonia (10%).

Pharmacyclics head of early development and immunotherapy Darrin Beaupre said: "This milestone marks the fifth patient population for whom Imbruvica is now approved and broadens the number of patients who may be treated with the medication.

“We continue to research Imbruvica across many disease areas, including but not limited to other B-cell malignancies."

Imbruvica blocks signals that tell malignant B cells to multiply and spread uncontrollably. It is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses.

Image: AbbVie US Headquarters - Angle 3. Photo: courtesy of AbbVie Inc. North Chicago, Illinois, U.S.A.