EC OKs AbbVie’s Imbruvica for Rare Blood Cancer
The European Commission (EC) has granted marketing authorization for AbbVie’s 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 US Food and Drug Administration approval for Imbruvica in January 2015. The approval of Imbruvica to treat patients with WM triggers a $20 million milestone payment from Janssen. Earlier this year, AbbVie acquired Pharmacyclics for $21 billion, and with the acquisition, Imbruvica.
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.
The drug is also approved in the US for treating CLL in patients who have received at least one prior therapy, all CLL patients (including treatment-naive) who have del 17p, a genetic mutation that occurs when part of chromosome 17 has been lost, and all patients (including treatment-naive) with Waldenstrom’s macroglobulinemia. It is also approved under accelerated approval for treating MCL in patients who have received at least one prior therapy.
Imbruvica is an oral, once-daily therapy that inhibits a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells. Imbruvica blocks signals that tell malignant B cells to multiply and spread uncontrollably.
Imbruvica is being studied alone and in combination with other treatments in several blood cancers.