IMBRUVICA was developed by AbbVie’s Pharmacyclics LLC and Janssen Biotech Inc. | File photo
+ Regulatory
Keri Carbaugh | Jan 24, 2017

FDA approves marginal zone lymphoma treatment

The U.S. Food and Drug Administration approved AbbVie’s IMBRUVICA for treatment of relapsed/refractory (R/R) marginal zone lymphoma (MZL) in patients who require systemic therapy and have received at least one prior anti-CD 20-based therapy.

IMBRUVICA was developed by AbbVie’s Pharmacyclics LLC and Janssen Biotech Inc.

"The FDA approval of IMBRUVICA for relapsed/refractory marginal zone lymphoma is significant, and we are proud of the culmination of this extensive clinical research program, representing the first approved treatment specifically for patients with this rare type of non-Hodgkin's lymphoma," Dr. Darrin Beaupre, head of Early Development and Immunotherapy at Pharmacyclics, 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."

The top side effects of IMBRUVICA were thrombocytopenia, fatigue and anemia. 

"In the Phase 2 trial, IMBRUVICA demonstrated impressive response rates and duration of response in relapsed/refractory marginal zone lymphoma patients," Dr. Ariela Noy, hematologic oncologist at Memorial Sloan Kettering Cancer Center in New York and lead investigator of the study, said. "The hematology-oncology community welcomes a new option like IMBRUVICA, which helps fill a significant treatment gap for previously treated MZL patients who are in need of non-chemotherapy options."

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