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AbbVie Announces U.S. FDA Approval of IMBRUVICA plus Obinutuzumab

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AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. 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.1IMBRUVICA 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.

'This latest IMBRUVICA FDA approval gives the healthcare community the first chemotherapy-free, anti-CD20 combination to treat CLL and SLL patients who have not yet started therapy. Also, and importantly, this new treatment combination helps reduce the need for chemotherapy,' said Carol Moreno, M.D., Ph.D., Consultant Hematologist, Hospital de la Santa Creu Sant Pau, Autonomous University of Barcelona, Barcelona, Spain, and lead investigator of the iLLUMINATE study.

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

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