The positive opinion is based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated the efficacy and safety of ibrutinib plus venetoclax in patients with previously untreated CLL,
If approved, this will be the first all-oral, once daily, fixed-duration, combination regimen for first-line treatment of CLL
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of a new treatment option with IMBRUVICA® (ibrutinib) in an oral fixed-duration combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL).
Outcomes for patients with CLL have improved in the last decade with the advent of oral therapies that target the underlying disease biology. This provides the opportunity to combine these novel treatments for an effective and convenient approach that results in deep responses with time-limited therapy. If approved, I+V will be the first all-oral, once daily, fixed-duration combination treatment with a Bruton’s tyrosine kinase (BTK) inhibitor for first-line treatment of patients with CLL.
“With this innovative treatment regimen, healthcare professionals would have the flexibility to use ibrutinib either in a fixed-duration combination or as a continuous therapy, helping them to better tailor frontline CLL therapy based on patients’ individual needs,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “This recommendation brings us one step closer to European Commission (EC) approval and to providing patients with an all-oral, once daily, fixed-duration regimen, which until this point has not been available with the BTK inhibitor class of treatments.”
The CHMP positive opinion is supported by data from the pivotal Phase 3 GLOW study (NCT03462719), which demonstrated that I+V was superior to chlorambucil-obinutuzumab with respect to the primary endpoint, progression-free survival (PFS), in elderly or unfit patients with CLL (PFS hazard ratio [HR]: 0.216; 95 percent confidence interval [CI], 0.131 to 0.357; P<0.001). It is also supported by the fixed-duration cohort of the Phase 2 CAPTIVATE study (NCT02910583) which evaluated I+V in 159 patients with previously untreated CLL who were 70 years or younger, including patients with high-risk CLL disease.
Data from these studies were recently published in NEJM Evidence, and Blood, respectively,, and featured as oral presentations at the European Hematology Association (EHA) 2021 Congress. Secondary analyses from GLOW, with additional study follow-up, were presented at the American Society of Hematology (ASH) 2021 Annual Meeting, and additional data from the CAPTIVATE study including clinical outcomes at three years and evidence of immune restoration post-treatment were recently presented at the EHA 2022 Congress.
“The promising data from GLOW and CAPTIVATE reinforce the distinct and complementary modes of action between ibrutinib and venetoclax, and the potential of this combination regimen to provide treatment-free remissions for patients,” said Craig Tendler, M.D., Global Head of Late Development, Diagnostics & Medical Affairs, Hematology & Oncology, Janssen Research & Development, LLC. “The positive CHMP opinion for I+V is testament to our commitment and continued leadership in developing innovative and convenient treatment regimens that may help improve outcomes for people living with complex blood cancers like CLL.”
Ibrutinib is a once-daily oral medication that is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. Ibrutinib blocks the Bruton’s tyrosine kinase (BTK) protein, which is needed by normal and abnormal B-cells, including specific cancer cells, to multiply and spread. By blocking BTK, ibrutinib may help move abnormal B-cells out of their nourishing environments and inhibits their proliferation.
Ibrutinib is approved in more than 100 countries and has been used to treat more than 250,000 patients worldwide. There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, over 11 years evaluating the efficacy and safety of ibrutinib., In October 2021, ibrutinib was added to the World Health Organization’s Model Lists of Essential Medicines (EML), which refer to medicines that address global health priorities and which should be available and affordable for all.
Ibrutinib was first approved by the European Commission (EC) in 2014, and approved indications to date include:
As a single agent or in combination with rituximab or obinutuzumab for the treatment of adult patients with previously untreated CLL
As a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy
As a single agent for the treatment of adult patients with relapsed or refractory (RR) mantle cell lymphoma (MCL)
As a single agent for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy, and in combination with rituximab for the treatment of adult patients with WM
For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
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