European Medicines Agency Issues Positive Opinion for the Use of IMBRUVICA® (ibrutinib)

AbbVie, a global biopharmaceutical company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion in favor of the use of IMBRUVICA® (ibrutinib) for the treatment of adult patients with previously-untreated chronic lymphocytic leukemia (CLL) in the European Union (EU).


The positive CHMP recommendation follows the March 4, 2016 U.S. Food and Drug Administration (FDA) approval of IMBRUVICA for the first-line treatment of patients with CLL.1 If approved by the European Commission (EC), this would be the fifth treatment indication for IMBRUVICA in the EU to date.

CLL is a chronic disease, and the prevalence rate in Europe among men and women is approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.2 An expansion of the CLL indication in Europe would mean a larger number of CLL patients, in addition to those with the genetic mutations del 17p or TP53, could initiate their treatment with a safe and effective oral alternative option to chemotherapy, rather than having to wait until they have become relapsed or refractory on another treatment option.

IMBRUVICA is jointly developed and commercialized in the U.S. by Pharmacyclics LLC, an AbbVie company 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), adult patients with CLL who have received at least one prior therapy or who have del 17p or TP53 mutations, and adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy, or as a first-line treatment for WM patients unsuitable for chemo-immunotherapy.3 The EC will review the CHMP opinion and is expected to render a final decision on the use of IMBRUVICA for previously untreated patients with CLL later this year.

“If approved by the European Commission, IMBRUVICA will be available as a treatment option for all CLL patients, including those who are treatment-naïve. The ability to offer a safe and effective, oral, single-agent alternative to chemotherapy in the first-line setting is a landmark few therapies are able to reach,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “The fact that IMBRUVICA has been granted this initial recommendation in the first-line setting is a testament to the dedication of those working on the compound to improve the lives of patients around the world who are suffering from CLL.”

The positive CHMP opinion was based on data from the Phase 3, randomized, open-label RESONATE™-2 (PCYC-1115) trial, which were presented at the American Society of Hematology (ASH) Annual Meeting in December 2015 and simultaneously published in The New England Journal of Medicine (NEJM). After a median of 18 months of follow-up, IMBRUVICA was associated with a significant improvement in all efficacy endpoints versus chlorambucil in patients aged 65 or older with newly diagnosed CLL. Specifically, IMBRUVICA was associated with a 90% progression-free survival (PFS; the primary endpoint) rate versus 52% for chlorambucil. Moreover, IMBRUVICA significantly prolonged overall survival (OS; a key secondary endpoint), with a 24-month survival rate of 98% versus 85% for chlorambucil (HR: 0.16; 95% CI, 0.05, 0.56). The safety of IMBRUVICA in the treatment-naïve CLL patient population was consistent with previously reported studies.