European Medicines Agency Issues Positive Opinion, Recommends Full Approval of IMBRUVICA® (ibrutinib) to Treat Waldenstrom's Macroglobulinemia
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.
The European Medicines Agency is an agency of the European Union responsible for the scientific evaluation of medicines submitted for approval by pharmaceutical companies for use in the 28 countries of the European Union. The positive CHMP opinion will be reviewed by the European Commission, and a final decision on IMBRUVICA to treat WM is anticipated in the second half of 2015. In addition to European markets, a worldwide regulatory filing program for IMBRUVICA currently is underway.
"We are very pleased that patients with WM in the European Union will have a first-in-class, oral, single-agent, non-chemotherapy treatment option in IMBRUVICA," said Thorsten Graef, M.D., Ph.D., Head of Hematology at Pharmacyclics. "This approval underscores the compelling safety and efficacy profile of IMBRUVICA in hematologic malignancies and we look forward to addressing the unmet medical needs of WM patients across Europe."
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