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FDA Approves Ibrutinib for Marginal Zone Lymphoma

Peter F. Lebowitz, MD, PhD

Ariela Noy, MD

The FDA has granted an accelerated approval to ibrutinib (Imbruvica) as a treatment for patients who require systemic therapy with marginal zone lymphoma (MZL) following at least one prior anti-CD20-based therapy, based on findings from a single-arm phase II study.

In the pivotal 60-patient open-label study, the objective response rates (ORR) with ibrutinib was 48%, with a complete response rate of 3%, according to findings presented at the 2016 ASH Annual Meeting. The median progression-free survival was 14.2 months with ibrutinib (95% CI, 8.3-NR) and the median overall survival was not yet reached at a median follow-up of 19.4 months.

"This approval broadens the indication for Imbruvica to include relapsed/refractory marginal zone lymphoma. It addresses a great unmet need for patients living with this serious blood cancer," Peter F. Lebowitz, MD, PhD, Global Oncology Head, Janssen, said in a statement. "Building on our longstanding commitment of providing meaningful treatment solutions for people living with hematological malignancies, this milestone marks the fifth blood cancer indication for this medication. We continue to research its potential across a range of B-cell malignancies based on the drug's mechanism of action." Click here to read the full article at

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