BEERSE, BELGIUM - The Janssen Pharmaceutical Companies of Johnson & Johnson 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
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