European Commission approves Imbruvica (ibrutinib) to treat Waldenstrom's macroglobulinemia- Pharmacyclics LLC +Janssen Cilag

AbbVie has announced the European Commission (EC) granted marketing authorization for Imbruvica (ibrutinib) as the first treatment option available in all 28 member states of the European Union (EU) for the treatment of Waldenstrom's macroglobulinemia (WM), a rare, slow growing blood cancer, in adult patients who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

Pharmacyclics LLC, an AbbVie company, received FDA approval for Imbruvica, which is also the first and only FDA-approved treatment for WM in the United States, in January 2015.

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 use in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

Comment: Long term data from an investigator-initiated study showed an overall response rate (ORR) of 91% after a median of 19.1 months of treatment and a 2-year overall survival (OS) rate of 95%. These updated results were published online in The New England Journal of Medicine.