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Independent Data Monitoring Committee Recommends Early Stopping of Phase 3 Study of Ibrutinib in Relapsed/Refractory CLL/SLL Patients Based on a Planned Interim Analysis
Date:1/7/2014

observed. The IDMC agreed that these results suggest evidence of clinical benefit as well as a tolerable safety profile in patients receiving ibrutinib as compared to intravenous doses of ofatumumab. The IDMC also recommended that the sponsor provide access to ibrutinib to patients in the ofatumumab arm. 

These results will be presented at an upcoming medical meeting and also will be submitted for publication in a peer-reviewed journal.

About Ibrutinib (IMBRUVICA™)

Ibrutinib was approved in November 2013 in the U.S. under the tradename IMBRUVICA™, as a single agent for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established.   

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage – Five percent (5%) of patients with MCL had Grade 3 or higher bleeding events (subdural hematoma, gastrointestinal bleeding, and hematuria). Bleeding events including bruising of any grade occurred in 48% of patients with MCL treated with 560 mg daily. The mechanism for the bleeding events is not well understood. Consider the benefit-risk of ibrutinib in patients requiring antiplatelet or anticoagulant therapies and the benefit-risk of withholding ibrutinib for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections – Fatal and non-fatal infections have occurred. At least 25% of patients with MCL had infections greater than or equal to Grade 3, according to NCI Common Terminology Criteria for Adverse Events (CTCAE). Monitor patients for fever and infections and evaluate promptly.

Myelosuppression – Treatment-emergent Grade 3 or 4 cytopenias were reported in 41% of patients. These included neutropenia (29%), th
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SOURCE Janssen Research & Development, LLC
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