Approval Sought for Ibrutinib, Venetoclax Combination Therapy in Patients With Chronic Lymphocytic Leukemia

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new fixed- duration treatment option for ibrutinib in combination with venetoclax in patients with previously untreated chronic lymphocytic leukemia (CLL), according to a press release. The application is based on the results of the phase 3 GLOW and phase 2 CAPTIVATE studies.

"Ibrutinib was the first approved Bruton’s tyrosine kinase inhibitor and over the past 7 years has become a key treatment for CLL and some other B-cell malignancies, treating more than 250,000 patients globally,” said Edmond Chan, MD, MSc, in a press release. “This latest submission is a testament to our unwavering commitment to meeting patient needs and a noteworthy step towards an innovative, non-chemotherapy treatment regimen in the first-line setting that will allow healthcare professionals the flexibility to use ibrutinib either in a fixed-duration combination treatment regimen or as continuous therapy, depending on patient needs.”

According to Janssen, the submission is supported by positive data in the GLOW study, which investigated the efficacy and safety of first-line fixed-duration ibrutinib and venetoclax combination therapy compared to chlorambucil plus obinutuzumab in elderly or unfit patients with CLL. Further, positive data from the CAPTIVATE study evaluating ibrutinib plus venetoclax in previously untreated CLL patients 70 years of age or younger, including patients with high-risk disease, was found to support this new indication.

“Ibrutinib and venetoclax have demonstrated positive outcomes when used together for a fixed duration of treatment and this milestone highlights our commitment to developing more convenient treatment regimens for people living with complex blood cancers, such as CLL,” said Craig Tendler, MD, vice president of Late Clinical Development and Global Medical Affairs in the Oncology department of Janssen Research & Development, in the release. “We now look forward to working in partnership with health authorities to bring this promising treatment option to patients who may benefit from it as soon as possible.”

CLL is a typically slow-growing blood cancer that affects the white blood cells, with an overall incidence in Europe of approximately 4.92 cases per 100,000 persons per year. The median age of patients diagnosed with the disease is 72 years.

According to the investigators, although patient outcomes have improved in recent decades, the disease is still characterized by consecutive episodes of disease progression. As a result, patients are frequently prescribed multiple lines of therapy as they relapse or become resistant to treatments, the researchers noted.

REFERENCE

Janssen seeks approval of Imbruvica®(ibrutinib) in a fixed-duration regimen for patients with untreated chronic lymphocytic leukaemia (CLL) [news release]. Janssen; November 30, 2021. Accessed December 2, 2021. https://www.jnj.com/janssen-seeks-approval-of-imbruvica-ibrutinib-in-a-fixed-duration-regimen-for-patients-with-untreated-chronic-lymphocytic-leukaemia-cll