Ibrutinib and Obinutuzumab Combo Granted Approval for CLL/SLL

The U.S. Food and Drug Administration (FDA) approved the combination of ibrutinib and obinutuzumab for the treatment of patients with treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

The agency’s decision was based on results from the phase III iLLUMINATE trial, which compared the efficacy of the ibrutinib-obinutuzumab combination with chlorambucil plus obinutuzumab in 229 patients with treatment-naïve CLL/SLL. At a median follow-up of 31 months (interquartile range = 29.4-33.2 months), the median progression-free survival was significantly longer in the ibrutinib-treated patients (not reached vs. 19 months; p<0.0001). This translated to a significantly lower risk of disease progression or death with the ibrutinibbased combination (hazard ratio = 0.23; 95% CI 0.15-0.37; p<0.0001).

The most common adverse events (AEs; occurring in ≥20% of patients) in the ibrutinib-treated arm included neutropenia, thrombocytopenia, rash, diarrhea, musculoskeletal pain, bruising, cough, infusion-related reaction, hemorrhage, and arthralgia.

Source: Janssen press release, January 28, 2019.

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