IMBRUVICA (ibrutinib) approved in Europe for treatment of Waldenstrom's macroglobulinemia

Today AbbVie (NYSE: ABBV) 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. The approval of IMBRUVICA to treat patients with WM triggers a $20 million milestone payment from Janssen.

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 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," said Wulff-Erik von Borcke, President of Pharmacyclics. "We are happy that IMBRUVICA will now be available to help patients in Europe who are living with Waldenstrom's."

The EC approval was based on data from a Phase II multi-center study, which evaluated the efficacy and tolerability of IMBRUVICA 420 mg once daily in 63 patients with WM who had received a median of two prior therapies (range 1-9). Updated results from the study were published in The New England Journal of Medicine and showed IMBRUVICA was associated with a 91% overall response rate (ORR; the primary endpoint) after a median follow up of 19 months (range 0.5-29.7), as assessed by investigators using criteria adopted from the International Workshop of Waldenstrom's Macroglobulinemia. Eleven patients (17%) achieved a minor response (MR), 36 patients (57%) achieved a partial response (PR) and 10 patients (16%) achieved a very good PR. The median times for patients to achieve at least minor and partial responses with treatment were four weeks and eight weeks respectively.

Secondary endpoints included progression-free survival (PFS) and safety. Estimated PFS and overall survival (OS) rates at 24 months were 69% (95% CI, 53.2 to 80.5) and 95% (95% CI, 86.0 to 98.4), respectively. The most commonly occurring adverse reactions in WM patients treated with IMBRUVICA (>20%) were neutropenia, thrombocytopenia, diarrhea, rash, nausea, muscle spasms, and fatigue. Six percent of patients receiving IMBRUVICA in the WM trial discontinued treatment due to adverse events. Overall, IMBRUVICA was well-tolerated and the safety profile was consistent with previous observations.




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