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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

ost frequent adverse reaction leading to treatment discontinuation was subdural hematoma (1.8%). Adverse reactions leading to dose reduction occurred in 14% of patients.

Drug Interactions:

CYP3A Inhibitors – Avoid concomitant administration with strong or moderate inhibitors of CYP3A. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA dose.

CYP3A Inducers – Avoid co-administration with strong CYP3A inducers.

Special Populations – Hepatic Impairment – Avoid use in patients with baseline hepatic impairment.

For the full prescribing information, visit http://www.imbruvica.com/downloads/Prescribing_Information.pdf

Ibrutinib has been submitted to the European Medicines Agency (EMA) for the treatment of adult patients with relapsed or CLL/SLL or adult patients with relapsed or refractory MCL. Use of ibrutinib in markets and for indications in which it has not been approved is investigational.

Ibrutinib is being jointly developed and commercialized by Janssen and Pharmacyclics, Inc. Pharmacyclics sponsored the study.

For more information, visit www.IMBRUVICA.com.

About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia (CLL) is a slow-growing cancer of the white blood cells (lymphocytes), most commonly B cells. CLL is the most common adult leukemia. Small Lymphocytic Lymphoma (SLL) is a slow-growing lymphoma in which too many immature white blood cells cause lymph nodes to become larger than normal.

About Janssen Research & Development, LLC

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our
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SOURCE Janssen Research & Development, LLC
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