Imbruvica is approved in all 28 member states of the European Union (EU) to treat adults with WM who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
The approval is based on data from a Phase II multi-center trial, which evaluated the efficacy and tolerability of Imbruvica 420mg once daily in 63 patients with WM who had received a median of two prior therapies.
Updated results from the trial showed Imbruvica was associated with a 91% overall response rate after a median follow up of 19 months, as assessed by investigators using criteria adopted from the International Workshop of Waldenstrom’s Macroglobulinemia.
Earlier this year, AbbVie company Pharmacyclics has received approval from the US Food and Drug Administration (FDA) for Imbruvica, which is also the first and only FDA-approved treatment for WM in the US.
The company said that the approval of Imbruvica to treat patients with WM triggers a $20m milestone payment from Janssen.
In the US, Imbruvica is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, while Janssen-Cilag International (Janssen) holds the marketing authorization of the product in Europe, and its affiliates market the drug in EMEA, as well as the rest of the world.
In Europe, Imbruvica is already approved 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 use in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
Pharmacyclics president Wulff-Erik von Borcke said: "The European Commission approval of IMBRUVICA as the first and only agent approved for patients with Waldenstrom’s macroglobulinemia across the EU underscores its value for patients with serious medical needs, unaddressed so far.
"We are happy that Imbruvica will now be available to help patients in Europe who are living with Waldenstrom’s."
Image: The EC approval is based on data from a Phase II trial of Imbruvica 420mg once daily in 63 patients with WM. Photo: courtesy of rakratchada torsap.