IMBRUVICA® (ibrutinib) Seeks to Expand U.S. Label with Long-Term Data in Waldenström's Macroglobulinemia (WM)

June 24, 2020 News /BioonBIOON/ -- AbbVie recently announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental new drug application (sNDA) for the targeted anticancer drug Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström's macroglobulinemia (WM). WM is a rare, incurable non-Hodgkin lymphoma (NHL). This sNDA aims to, through the Phase III iNNOVATEClinical TrialsOver 5 years of data analysis have led to updates in the US prescribing information for Imbruvica. This also represents the longest follow-up data currently available for BTK inhibitor therapy in Waldenström's macroglobulinemia (WM).

Imbruvica is an oral Bruton's tyrosine kinase (BTK) inhibitor, jointly developed and commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech, Inc., a Johnson & Johnson company. Imbruvica was first approved in 2015 as a monotherapy for the treatment of WM, becoming the first and onlyFDADrugs Approved for the Treatment of WM. In 2018, Imbruvica was also approved in combination with rituximab for the treatment of WM, becoming the first chemotherapy-free combination regimen for WM. To date, Imbruvica remains the only BTK inhibitor approved for the treatment of WM.

The iNNOVATE (PCYC-1127) study was conducted in patients with Waldenström’s macroglobulinemia (WM) who were either treatment-naïve or had relapsed/refractory disease, evaluating the efficacy and safety of Imbruvica plus rituximab versus rituximab plus placebo. Previously reported results showed that, with a median follow-up of 30 months, progression-free survival (PFS) was significantly improved in the Imbruvica plus rituximab group compared to the rituximab plus placebo group (PFS rate: 82% vs. 28%; HR=0.20; p<0.001). Long-term analysis results from this study will be presented at upcoming medicalMeetingpublished above.

Danelle James, Global Head of Development for Imbruvica at Pharmacyclics, an AbbVie company, stated, “Since Imbruvica becameFDASince its approval as the first therapy for WM, it has significantly transformed the treatment landscape for this rare, incurable form of non-Hodgkin lymphoma. This latest application will further underscore how Imbruvica provides innovative treatment options for patients with WM, as well as our commitment to supporting this patient community.”

Waldenström macroglobulinemia (WM) typically affects older adults and primarily involves the bone marrow, although lymph nodes and the spleen may also be affected. In the United States, there are approximately 2,800 new cases of WM each year. In May 2020, the National Comprehensive Cancer Network (NCCN) recommended Imbruvica, with or without rituximab, as a preferred regimen for patients with WM, including as a Category 1 preferred option for initial therapy.

Dr. Meletios A. Dimopoulos, Professor and Chair of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, and Chief Investigator of the iNNOVATE study, stated: “We have made significant progress in the treatment of WM. Until a few years ago, treatment options for this disease were limited, including chemotherapy. The iNNOVATE study continues to provide robust clinical evidence supporting the long-term use of Imbruvica in combination with rituximab for both first-line and second-line treatment of patients with WM.”

Imbruvica is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor administered orally once daily,Exerts anticancer effects by inhibiting BTK, which is required for the proliferation and metastasis of cancer cells. BTK is a key signaling molecule in the B-cell receptor signaling complex and plays an important role in the survival and metastasis of malignant B cells, as well as in various other serious debilitating diseases. Imbruvica can block the signaling pathways that mediate the uncontrolled proliferation and spread of B cells, helping to kill cancer cells and reduce their number, thereby delaying cancer progression. InClinical TrialIn China, monotherapy and combination therapies targeting a broad range of hematologic malignanciesTumorDemonstrated robust efficacy.

Since its launch in 2013, Imbruvica has received 11 approvals across a total of six indications, including five B-cell hematologic malignancies and chronic graft-versus-host disease (cGVHD).FDAApproval: Chronic lymphocytic leukemia with or without 17p deletion mutation (del17p)Leukemia(chronic lymphocytic leukemia [CLL]), small lymphocytic lymphoma (SLL) with or without 17p deletion mutation (del[17p]), Waldenström macroglobulinemia (WM), previously treated mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) requiring systemic therapy and having received at least one prior anti-CD20 therapy, and chronic graft-versus-host disease (cGVHD) that has failed one or more systemic therapies.

To date, Imbruvica has been used to treat more than 200,000 patients worldwide across its approved indications, including 5,300 patients with Waldenström’s macroglobulinemia (WM) in the United States.

Currently, AbbVie and Johnson & Johnson are advancing a large-scale Imbruvica clinicalTumorDevelopment Project. The industry holds a very optimistic view of the commercial prospects for Imbruvica. An article titled “Top product forecasts for 2020,” published in January in the premier international journal Nature Reviews Drug Discovery, predicted that Imbruvica’s global sales would reach $6.818 billion in 2020. Pharmaceutical market research firm EvaluatePharma also forecasted that Imbruvica would generate an additional $1 billion in sales in 2020, with global sales reaching $9.5 billion by 2024, driven by continuous market penetration and an expanding range of indications. (Bioon.com)

Original Source: IMBRUVICA® (ibrutinib) Seeks to Expand U.S. Label with Long-Term Data in Waldenström's Macroglobulinemia (WM)