AbbVie’s BTK Inhibitor Imbruvica US Prescription Information Will Be Updated: Include 5-year Long-term Data

- Jul 03, 2020-

AbbVie recently announced that the US Food and Drug Administration (FDA) has accepted the targeted anti-cancer drug Imbruvica (ibrutinib) combined with rituximab (rituximab) to treat Waldenström's macroglobulinemia, WM) Supplemental New Drug Application (sNDA). WM is a rare and incurable non-Hodgkin's lymphoma (NHL). The sNDA aims to update the US prescription information of Imbruvica through data analysis of the phase III iNNOVATE clinical trial for more than 5 years. This is also the longest follow-up data currently available for BTK treatment of WM.

Imbruvica is an oral Bruton tyrosine kinase (BTK) inhibitor, jointly developed and commercialized by AbbVie's Pharmacyclics and Johnson & Johnson's Janssen Biotechnology. Imbruvica was first approved as a monotherapy for WM in 2015, becoming the first and only FDA approved drug to treat WM. In 2018, Imbruvica was also approved in combination with rituximab to treat WM, becoming the first non-chemotherapy combination therapy for WM. As of now, Imbruvica is the only BTK inhibitor approved for the treatment of WM.

The iNNOVATE (PCYC-1127) study was conducted in previously untreated WM patients and patients with relapsed/refractory WM, and evaluated the efficacy and efficacy of the Imbruvica + rituximab regimen compared to the rituximab + placebo regimen. safety. Previously published results showed that after a median follow-up of 30 months, Imbruvica+rituximab-treated patients had significantly improved disease-free survival compared to the rituximab+placebo group (progression-free survival rate: 82% vs 28 %, HR=0.20, p<0.001). The results of the long-term analysis from the study will be announced at a future medical conference.

Danelle James, head of global development for Imbruvica, a subsidiary of AbbVie’s Pharmacyclics, said: "Since Imbruvica became the first FDA-approved drug for WM more than five years ago, it has significantly changed this rare, incurable non-Ho Chikin's lymphoma treatment pattern. This latest application will strengthen how Imbruvica provides innovative treatment options for WM patients and our commitment to support this patient community."

WM usually affects the elderly, mainly in the bone marrow, although lymph nodes and 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) has recommended Imbruvica with or without rituximab as the first choice for patients with WM, including a Class I priority regimen for WM primary treatment.

Dr. Meletios a. Dimopoulos, chief investigator of iNNOVATE research, professor and chairman of the Department of Clinical Therapeutics of the National Medical College of Athens and Capodister University School of Medicine, said: "We have made significant progress in the treatment of WM. Until a few years ago, the Treatment options for the disease are still very limited, including chemotherapy. The iNNOVATE study continues to provide strong clinical evidence to support the long-term use of Imbruvica combined with rituximab in first- and second-line treatment of WM patients."

11 indications for 6 diseases: sales will reach USD 6.8 billion in 2020 and USD 9.5 billion in 2024


Imbruvica is the first Bruton tyrosine kinase (BTK) inhibitor to be taken orally once a day. It exerts an anticancer effect by blocking BTK required for cancer cell proliferation and metastasis. 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 and many other severe debilitating diseases. Imbruvica can block the signaling pathways that mediate the uncontrolled proliferation and spread of B cells, help kill and reduce the number of cancer cells, and delay the progression of cancer. In clinical trials, single drugs and combination therapies have demonstrated powerful efficacy against a wide range of hematological malignancies.

Since its launch in 2013, Imbruvica has received 11 FDA approvals in a total of 6 disease areas including 5 B-cell blood cancers and chronic graft-versus-host disease (cGVHD): chronic with or without 17p deletion mutation (del17p) Lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) with or without 17p deletion mutation (del17p), Waldenstrom macroglobulinemia (WM), previously treated mantle cell lymphoma (MCL), Marginal zone lymphoma (MZL) that requires systematic treatment and has received at least one anti-CD20 therapy, chronic graft-versus-host disease (cGVHD) that has failed treatment with one or more systemic therapies.

To date, Imbruvica has been used in the approved indications to treat more than 200,000 patients worldwide, including 5,300 WM patients in the United States.

At present, AbbVie and Johnson & Johnson are advancing a huge Imbruvica clinical tumor development project. The industry is very optimistic about Imbruvica's business prospects. In January this year, an article published in the top international journal "Natural-Drug Discovery Review" (Top product forecasts for 2020) predicted that Imbruvica's global sales in 2020 will reach $6.818 billion. EvaluatePharma, a pharmaceutical market research organization, also predicts that Imbruvica will add $1 billion in sales in 2020. With continued market penetration and increasing indications, global sales will reach $9.5 billion in 2024.