Umbrella Organization of European Waldenström patient supportgroups and patients


Ibrutinib in Europe - Important update

Go back to newsInserted on Monday 8 December 2014
The Imbruvica/ Ibrutinib Application for treatment of Waldenström's
Macroglobulinemia (WM) has been accepted by the European Medicines Agency.
This is the first step to Registration.
If Registration is approved, IMBRUVICA would be the first label specifically authorized to treat WM.

The EMA WM filing follows the supplemental New Drug Application submission
for IMBRUVICA to the U.S. Food and Drug Administration (FDA), which was
submitted by Pharmacyclics in October 2014, for its use in the treatment of
patients with WM. Both the FDA and EMA filings were based on data from a
Phase II study evaluating the use of IMBRUVICA in WM patients, which was led
by Dr. Steven Treon from the Dana-Farber Cancer Institute.

It is too early to say when the drug will be available for actual use.
European clinical trials will be needed and the use of ibrutinib in the
individual countries of Europe will be a matter for the health regulatory
bodies in those countries. One factor influencing adoption, will be the
perceived cost-effectiveness of ibrutinib, as the drug is likely to be
considerably more expensive than other agents currently in use.

EWMnetwork will await developments and act when necessary.

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