AbbVie, a research-based global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved the use of Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The latest FDA approval expands the use of Imbruvica, which can already be administered as a single agent or in combination with bendamustine and rituximab (BR) for adult CLL/SLL patients. Imbruvica is a once-daily, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
Clinical Basis of Approval
The FDA approval is based on results from the phase 3 iLLUMINATE (PCYC-1130) study, which showed the combination of Imbruvica plus obinutuzumab significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab in previously untreated CLL/SLL patients who were 65 years or older, or less than 65 years old with coexisting conditions. Patients treated in the Imbruvica arm experienced a 77 percent reduction in risk of progression or death compared to the chlorambucil plus obinutuzumab arm (hazard ratio [HR] 0.23; 95% confidence interval [CI]: 0.15-0.37; P<0.0001). The chemotherapy-free, anti-CD20 combination regimen also showed an 85 per cent reduction in risk of progression or death compared to chlorambucil plus obinutuzumab (HR 0.15; 95% CI: 0.09-0.27) when evaluating PFS in patients with high-risk disease (17p deletion/TP53 mutation, 11q deletion, or unmutated IGHV). The data were recently presented in an oral session at the 2018 American Society of Hematology (ASH) Annual Meeting and simultaneously published in The Lancet Oncology.