PHARMACYCLICS, INC. FOR IMMEDIATE RELEASE
First therapy to be approved specifically for this disease in the EU
SUNNYVALE, Calif., July 10, 2015 - 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 Waldenström'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 2015.1 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 Waldenström'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 Waldenström'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,
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.
About Waldenström's macroglobulinemiaWM (a clinically recognized subset of lymphoplasmacytic lymphoma, or LPL) is a slow-growing and rare blood cancer that most commonly originates from B cells, a type of white blood cell (lymphocyte) that develops in the bone marrow.2 WM occurs as the result of a malfunction in the healthy lifecycle of a B cell, causing the cell to become malignant and reproduce at an abnormal rate. The malignant B cells produce large amounts of an abnormal type of antibody protein called immunoglobulin M (IgM). Excess IgM causes the blood to thicken and causes many of the symptoms of WM.2
About IMBRUVICAIMBRUVICA is currently approved in the US for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, all CLL patients (including treatment-naïve) who have del 17p, a genetic mutation that occurs when part of chromosome 17 has been lost, and all patients (including treatment-naïve) with Waldenström's
macroglobulinemia.1 IMBRUVICA is also approved under accelerated approval for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.1
IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK).1 IMBRUVICA was one of the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway, and is the only product to have received three Breakthrough Therapy Designations.
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.1,3 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.1
IMBRUVICA is being studied alone and in combination with other treatments in several blood cancers. Over 6,100 patients have been treated in clinical trials of IMBRUVICA conducted in 35 countries by more than 800 investigators. Currently, 13 Phase III trials have been initiated with IMBRUVICA and 67 trials are registered on www.clinicaltrials.gov.
To learn more about the medical terminology used in this news release, please visit http://stedmansonline.com/.
INDICATIONSIMBRUVICA is indicated in the US to treat people with:
Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy
Chronic lymphocytic leukemia (CLL) with 17p deletion
Waldenström's macroglobulinemia
Mantle cell lymphoma (MCL) who have received at least one prior therapy - accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
Patients taking IMBRUVICA for CLL or WM should take 420 mg taken orally once daily (or three 140 mg capsules once daily).
Patients taking IMBRUVICA for MCL should take 560 mg taken orally once daily (or four 140 mg capsules once daily).
Capsules should be taken orally with a glass of water. Capsules should be taken whole. Do not open, break, split or chew the capsules.
Hemorrhage - Fatal bleeding events have occurred in patients treated with IMBRUVICA®. Grade 3 or higher bleeding events (subdural hematoma, gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA®.
The mechanism for the bleeding events is not well understood. IMBRUVICA® may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies. Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding.
Infections - Fatal and non-fatal infections have occurred with IMBRUVICA® therapy. Grade 3 or greater infections occurred in 14% to 26% of patients. Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients treated with IMBRUVICA®. Monitor patients for fever and infections and evaluate promptly.
Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 19 to 29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 9%) occurred in patients treated with IMBRUVICA®. Monitor complete blood counts monthly.
Atrial Fibrillation - Atrial fibrillation and atrial flutter (range, 6 to 9%) have occurred in patients treated with IMBRUVICA®, particularly in patients with cardiac risk factors, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness) or new-onset dyspnea should have an ECG performed. If atrial fibrillation persists, consider the risks and benefits of IMBRUVICA® treatment and dose modification.
Pharmacyclics Inc. issued this content on 2016-01-07 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 2016-01-07 20:35:04 UTC
Original Document: http://www.pharmacyclics.com/docs/librariesprovider4/press-releases/2015/9_pcyc-abbv-ec-wm-approval-release-7-10-15.pdf?sfvrsn=4
