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News Breaks
April 8, 2014
08:05 EDTPCYCPharmacyclics files supplemental new drug application for Imbruvica
Pharmacyclics announced that it has submitted a supplemental New Drug Application to the FDA, based on data from the randomized, multi-center, open-label Phase III Resonatetm study, PCYC-1112, a head-to-head comparison of single agent Imbruvicatm versus ofatumumab in 391 patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, who had received at least one prior therapy. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech.
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October 20, 2014
08:14 EDTPCYCPharmacyclics files supplmeental NDA for Imbruvica for macroglobulinemia
Pharmacyclics (PCYC) announced that it has submitted a supplemental New Drug Application to the FDA based on data from a Phase 2 study evaluating the use of IMBRUVICA in patients with Waldenstrom's macroglobulinemia. IMBRUVICA, which received FDA Breakthrough Therapy Designation in February 2013 for patients with WM, is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech (JNJ).

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