The Food and Drug Administration (FDA) has approved Imbruvica (ibrutinib; Pharmacyclics and Janssen) in combination with obinutuzumab in treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), expanding the indication to include combination therapy as well as monotherapy. 

The approval was supported by data from the Phase 3 iLLUMINATE study (NCT02264574) in 212 adult patients. Treatment with Imbruvica + obinutuzumab led to a significant improvement in Independent Review Committee (IRC)-evaluated progression-free survival (PFS) vs chlorambucil + obinutuzumab after a median follow-up of 31 months (median not evaluable [NE] vs 19 months; hazard ratio [HR] 0.23, 95% CI, 0.15–0.37; P <.0001); for patients with high-risk disease (17p deletion/TP53 mutation, 11q deletion, or unmutated IGHV), the PFS HR was 0.15 (95% CI, 0.09–0.27). The overall response rate was 88.5% in the Imbruvica arm vs 73.3% in the chlorambucil arm. 

The Imbruvica labeling was also updated with long-term efficacy data supporting its use as monotherapy in CLL/SLL with ~5 years of follow-up from the Phase 3 RESONATE and RESONATE-2 studies.

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“Imbruvica as a single agent – and now as a combination with obinutuzumab – provides patients with CLL with an alternative to frontline treatment with chemoimmunotherapy,” said Carol Moreno, MD, PhD, Consultant Hematologist, Hospital de la Santa Creu Sant Pau, Autonomous University of Barcelona, Barcelona, Spain, and lead investigator of the iLLUMINATE study.

Imbruvica is available as 70mg and 140mg capsules and as 140mg, 280mg, 420mg, and 560mg strength tablets; obinutuzumab (Gazyva; Genentech) is available as a 25mg/mL strength solution for intravenous (IV) infusion. 

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