European Commission approves Imbruvika in a fixed-duration combination regimen for adult patients with previously untreated chronic lymphocytic leukaemia.-Janssen

The approval is based on the pivotal Phase III GLOW study that demonstrated superior progression-free survival (PFS) in patients treated with I+V versus chlorambucil-obinutuzumab (Clb+O), and the FD cohort of the Phase II CAPTIVATE study, which showed deep and durable responses in patients treated with I+V, including those with high-risk features.

In Europe, ibrutinib is already approved as a continuous therapy in several indications across three blood cancers (CLL, mantle cell lymphoma and Waldenström's macroglobulinaemia) In CLL, patient outcomes have improved over the last decade. A wave of innovation, including the advent of novel oral therapies that target the underlying disease biology, has shifted the standard of care from chemoimmunotherapy to targeted agents and combination therapies. Unmet needs remain, including time-limited combinations of targeted therapies that provide durable remissions and the flexibility to better tailor first-line therapy.

“The distinct and complementary mechanisms of action of ibrutinib and venetoclax, and the potential of this combination regimen to provide treatment-free remissions, mark important progress for how we approach first-line CLL therapy,” said Arnon Kater, M.D., Ph.D., Deputy Head of Haematology, Amsterdam University Medical Centres, University of Amsterdam and Chairman of the HOVON CLL Working Group, the Netherlands and GLOW principal study investigator. “These highly active blood cancer treatments not only combine to deliver superior progression-free survival versus chlorambucil plus obinutuzumab, but also demonstrate robust disease clearance in lymphoid tissue, blood and bone marrow, and early sustainability of those responses after stopping treatment.”