Policy & Regulation
European Commission Approves Imbruvica in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia
4 August 2022 - - The European Commission granted marketing authorisation for the expanded use of Imbruvica (ibrutinib) in an all-oral, fixed-duration treatment combination with venetoclax for adults with previously untreated chronic lymphocytic leukaemia, US-based healthcare company Johnson and Johnson's (NYSE: JNJ) Janssen subsidiary said.

The approval is based on the pivotal Phase 3 GLOW study that demonstrated superior progression-free survival in patients treated with I+V versus chlorambucil-obinutuzumab (Clb+O), and the FD cohort of the Phase 2 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 EC approval is supported by data from the pivotal Phase 3 GLOW study (NCT03462719), which demonstrated that I+V was superior to Clb+O with respect to the primary endpoint, PFS assessed by an independent review committee, in elderly or unfit patients with CLL (PFS hazard ratio [HR]: 0.216; 95 % confidence interval [CI], 0.131 to 0.357; P