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Pharmacyclics Reports Results for Six and Three Months Ended December 31, 2012
Date:2/14/2013

with Janssen, is working with the FDA to determine the implications of this Breakthrough Therapy Designation to the ongoing and planned development and the filing requirements for the use of ibrutinib in patients with mantle cell lymphoma (MCL) and in patients with Waldenstrom's macroglobulinemia (WM). The Company expects to finalize the MCL filing prior to year end and will provide guidance on the WM filing after further discussions with the FDA. Pharmacyclics will provide regulatory updates as further information on implementing the requirements with respect to Breakthrough Therapies are developed by the Secretary of Health and Human Services.

ASH 2012

Pharmacyclics had 9 oral and 9 poster presentations at this year's American Society of Hematology (ASH) Annual Meeting providing an update on the broad development program of ibrutinib.  Among the data presented at ASH were updates on the safety and efficacy of ibrutinib in the most mature clinical programs of chronic lymphocytic leukemia (CLL) and MCL. Two of the CLL oral presentations were acknowledged as 'Best of ASH' during the event. Additionally, investigators presented data in diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and multiple myeloma (MM).  Most of the oral presentations can be found on the Company's website. 

Phase II/III clinical trials initiated with ibrutinib in the collaboration:

  • Phase III study of ibrutinib versus ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL), RESONATE™. This trial is a randomized, multi-center, open-label Phase III trial of ibrutinib as a monotherapy. The primary endpoint of the study is to demonstrate a clinically significant improvement in progression-free survival when compared to ofatumumab. This global study is open and Pharmacyclics plans to enroll 350 patients worldwide. The Company anticipates having this st
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