AbbVie has received marketing approval from the European Commission (EC) for its Imbruvica (ibrutinib) to treat patients with Waldenstrom’s macroglobulinemia (WM), a rare and slow-growing blood cancer.
Approval was granted for the drug to treat WM in adult patients who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
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Imbruvica is a first-in-class, oral and once-daily therapy, which inhibits a protein known as Bruton’s tyrosine kinase (BTK).
In Europe, Janssen-Cilag International has marketing authorisation for the drug and its affiliates sells Imbruvica in Europe, Middle East, Africa (EMEA), as well as in different part of the world.
The European approval will result in Janssen paying around $20m in milestone payment to AbbVie.
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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."
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By GlobalDataApproval was based on data from a Phase II multi-centre study that assessed the efficacy and tolerability of Imbruvica 420mg once-daily in 63 patients with WM who had received a median of two prior therapies.
According to the firm, the study demonstrated Imbruvica was associated with a 91% overall response rate (primary endpoint) after a median follow up of 19 months.
Earlier, Imbruvica approved in Europe to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) and adult patients with chronic lymphocytic leukemia (CLL).
In January this year, AbbVie firm Pharmacyclics obtained FDA approval for Imbruvica to treat WM in the US. Pharmacyclics, along with Janssen Biotech, has developed and commercialised Imbruvica in the US.
Image: WM is a slow-growing and rare blood cancer that most commonly originates from B cells, a type of white blood cell (lymphocyte). Photo: courtesy of BruceBlaus.
