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EMA's Advisery Committee Recommends Full Approval of IMBRUVICA® (ibrutinib) to Treat Waldenstrom's Macroglobulinemia

Go back to newsInserted on Tuesday 2 June 2015


IBRUTINIB Would Become First European Medicines Agency (EMA)-approved Therapy for Waldenström-Patients in Europe

SUNNYVALE, Calif., May 22, 2015 /PRNewswire/ -- Pharmacyclics, Inc.(NASDAQ: PCYC) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending a change to the terms of the marketing authorization for IMBRUVICA® (ibrutinib) in the European Union to indicate the treatment of adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
1. WM is a rare, slow growing form of blood cancer.
2. IMBRUVICA is also the first and only FDA-approved treatment for WM in the United States.
3. The CHMP recommendation follows the January 2015 U.S. Food and Drug Administration
(FDA) full approval of IMBRUVICA to treat all lines of patients with WM.

IMBRUVICA is jointly developed and commercialized in the United States by Pharmacyclics and Janssen Biotech, Inc. In Europe, Janssen-Cilag International NV (Janssen) holds the marketing authorization and its affiliates market IMBRUVICA in EMEA (Europe, Middle East, Africa), as well as the rest of the world. IMBRUVICA is already approved in Europe to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) and adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

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