AbbVie Announces IMBRUVICA (ibrutinib) Plus Rituximab Approval by U.S. FDA as First Chemotherapy-Free Combination Treatment in Adults with Waldenstr?m's Macroglobulinemia, a Rare Type of
Milestone represents ninth FDA approval for IMBRUVICA in less than five years since its initial approval
- New approval of IMBRUVICA plus rituximab for Waldenstr?m's macroglobulinemia (WM) is supported by recent Phase 3 study data that showed a 30-month progression-free survival rate of 82 percent for patients on the combination therapy, versus 28 percent for patients on rituximab alone - Following Priority Review from the U.S. FDA, approval of the use of IMBRUVICA plus rituximab for adult patients with WM was received nearly two months in advance of anticipated date
- IMBRUVICA now has a total of nine FDA approvals across six different diseases
- New approval of IMBRUVICA plus rituximab for Waldenstr?m's macroglobulinemia (WM) is supported by recent Phase 3 study data that showed a 30-month progression-free survival rate of 82 percent for patients on the combination therapy, versus 28 percent for patients on rituximab alone - Following Priority Review from the U.S. FDA, approval of the use of IMBRUVICA plus rituximab for adult patients with WM was received nearly two months in advance of anticipated date
- IMBRUVICA now has a total of nine FDA approvals across six different diseases
NORTH CHICAGO, Ill.,?AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today?announced that the U.S. Food and Drug Administration (FDA) approved IMBRUVICA??(ibrutinib) plus rituximab (RITUXAN?)?for the treatment of adult patients with Waldenstr?m's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). With this approval, the IMBRUVICA prescribing information now includes combination use with rituximab, representing the first and only chemotherapy-free combination treatment specifically indicated for the disease. IMBRUVICA was first approved as a single agent therapy for WM in?January 2015. IMBRUVICA is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
"We are pleased to have IMBRUVICA approved, both as a single agent and combination therapy with rituximab, to provide an additional efficacious treatment option for people living with Waldenstr?m's macroglobulinemia," said?Thorsten Graef, M.D., Ph.D., Head of Clinical Development at Pharmacyclics LLC, an AbbVie company. "We are proud of our robust clinical development program, and this new approval reflects our continuous commitment to exploring the full potential of IMBRUVICA's mechanism of action for treating patients with diseases that have great unmet medical need."
This new FDA approval is supported by data from the Phase 3 iNNOVATE (PCYC-1127) trial evaluating IMBRUVICA in combination with rituximab, versus rituximab alone, in 150 patients with previously untreated and relapsed/refractory WM.?At a median follow up of 26.5 months, the study demonstrated a significant improvement in progression-free survival (PFS) with IMBRUVICA plus rituximab compared to rituximab alone (30-month PFS rates were 82 percent versus 28 percent, respectively). Patients taking IMBRUVICA plus rituximab also experienced an 80 percent reduction in relative risk of disease progression or death than those only treated with rituximab (hazard ratio, 0.20; confidence interval: 0.11-0.38, P<0.0001). These data were recently?presented?at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting and simultaneously published in?The New England Journal of Medicine.
"The iNNOVATE study demonstrated persuasive clinical evidence supporting the efficacy of IMBRUVICA plus rituximab in Waldenstr?m's macroglobulinemia," said Dr.?Meletios A. Dimopoulos, Professor and Chairman of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine,?Athens, Greece, and lead iNNOVATE study investigator.* "This approval is a significant milestone for the WM community who have limited treatment options."
"Ibrutinib has significantly advanced the treatment of Waldenstr?m's macroglobulinemia. The approval of ibrutinib and rituximab has added a new option for many Waldenstr?m's patients," said?Steven P. Treon, M.D., Ph.D., Director of the Bing Center for Waldenstr?m's Macroglobulinemia at the Dana-Farber Cancer Institute, Associate Professor at?Harvard Medical School, and lead investigator of the IMBRUVICA Phase 2 clinical trial which served as the basis for its?January 2015?FDA approval.*
WM is a rare, slow-growing and incurable form of NHL with limited treatment options. WM typically affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen also may be affected. In the U.S., there are about 2,800 new cases of WM each year.1
The most common adverse reactions (occurring in 20% or more of patients) of all Grades in patients treated with IMBRUVICA plus rituximab in the iNNOVATE study were bruising (37%), musculoskeletal pain (35%), hemorrhage (32%), diarrhea (28%), rash (24%), arthralgia (24%), nausea (21%), and hypertension (20%).
In combination with rituximab or as a single agent, the recommended dose of IMBRUVICA for adults with WM is 420 mg taken orally once daily until disease progression or unacceptable toxicity. When administering IMBRUVICA in combination with rituximab, consider administering IMBRUVICA prior to rituximab when given on the same day.
About iNNOVATE
iNNOVATE is a Pharmacyclics-sponsored, randomized, placebo-controlled, double-blind, Phase 3 study, which enrolled 150 patients with relapsed/refractory and treatment-na?ve Waldenstr?m's macroglobulinemia. Patients were randomized to receive intravenous rituximab 375 mg/m2?once weekly for four consecutive weeks, followed by a second four-weekly rituximab course following a three-month interval. All patients received either ibrutinib 420 mg or placebo once daily continuously until criteria for permanent discontinuation were met. The primary endpoint was progression-free survival, with secondary endpoints including overall response rate, hematological improvement measured by hemoglobin, time-to-next treatment, overall survival, and number of participants with adverse events as a measure of safety and tolerability within each treatment arm.
About?IMBRUVICA
IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that mainly works by blocking 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 as well as other serious, debilitating conditions.2?IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.
IMBRUVICA is FDA-approved in six distinct patient populations: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenstr?m's macroglobulinemia (WM), along with previously-treated mantle cell lymphoma (MCL), previously-treated marginal zone lymphoma (MZL) and previously-treated chronic graft-versus-host disease (cGVHD).3
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. IMBRUVICA is a registered trademark of Pharmacyclics LLC.
SOURCE AbbVie Inc. *Disclaimer: Dr. Dimopoulos and Dr. Treon served as investigators of a Pharmacyclics-sponsored clinical study. Dr. Dimopoulos and Dr. Treon do not have a financial interest in the company. 1?Lymphoma Research Foundation. Getting the facts: Waldenstr?m macroglobulinemia.?https://www.lymphoma.org/wp-content/uploads/2017/06/LRF_FACTSHEET_Waldenstro%CC%88m_Macroglobulinemia.pdf. Accessed?August 2018. 2?Genetics Home Reference. Isolated growth hormone deficiency.?http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed?August 2018. 3?IMBRUVICA U.S. Prescribing Information, August 2018 4?U.S. Food and Drug Administration. Fact sheet: breakthrough therapies.?https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm. Accessed?August 2018.
- IMBRUVICA was first approved for adult patients with MCL who have received at least one prior therapy in?November 2013.
- Soon after, IMBRUVICA was initially approved in adult CLL patients who have received at least one prior therapy in?February 2014. By?July 2014, the therapy received approval for adult CLL patients with 17p deletion, and by?March 2016, the therapy was approved as a frontline CLL treatment.
- IMBRUVICA was approved for adult patients with WM in?January 2015.
- In?May 2016, IMBRUVICA was approved in combination with bendamustine and rituximab (BR) for adult patients with previously-treated CLL/SLL.
- In?January 2017, IMBRUVICA was approved for adult patients with MZL who require systemic therapy and have received at least one prior anti-CD20-based therapy.
- In?August 2017, IMBRUVICA was approved for adult patients with cGVHD that failed to respond to one or more lines of systemic therapy.
- In?August 2018, IMBRUVICA plus rituximab was approved for adult patients with WM.
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. IMBRUVICA is a registered trademark of Pharmacyclics LLC.
SOURCE AbbVie Inc. *Disclaimer: Dr. Dimopoulos and Dr. Treon served as investigators of a Pharmacyclics-sponsored clinical study. Dr. Dimopoulos and Dr. Treon do not have a financial interest in the company. 1?Lymphoma Research Foundation. Getting the facts: Waldenstr?m macroglobulinemia.?https://www.lymphoma.org/wp-content/uploads/2017/06/LRF_FACTSHEET_Waldenstro%CC%88m_Macroglobulinemia.pdf. Accessed?August 2018. 2?Genetics Home Reference. Isolated growth hormone deficiency.?http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed?August 2018. 3?IMBRUVICA U.S. Prescribing Information, August 2018 4?U.S. Food and Drug Administration. Fact sheet: breakthrough therapies.?https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm. Accessed?August 2018.
SOURCE AbbVie
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