On May 22, 2015, Pharmacyclics, Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) issued a positive opinion recommending that Imbruvica (ibrutinib) be approved to treat WM patients who have received at least one prior therapy or as first line treatment for WM patients unsuitable for chemo-immunotherapy. The CHMP recommendation follows the January 2015 US Food and Drug Administration (FDA) full approval of Imbruviea to treat all lines of patients with WM.
The EMA is an agency of the European Union responsible for the scientific evaluation of medicines used in the 28 countries of the European Union. The opinion of the Committee will be reviewed by the EMA, and a final decision is anticipated in the second half of 2015. If the final decision is positive, this would mark the first EMA-approved therapy for WM patients in Europe.
The original version of the Pharmacyclics announcement on PR Newswire is here(link is external),