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FDA Expands Indications for Imbruvica

January 29, 2019

The Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Imbruvica (ibrutinib; AbbVie and Janssen Biotech Inc.) for use in combination with Gazyva (obinutuzumab; Genentech) for treatment of adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Imbruvica was previously FDA-approved for use as a single agent or in combination with bendamustine and rituximab for adult CLL/SLL patients.

Imbruvica is a once-daily, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally. The expanded FDA approval was based on results from the phase III iLLUMINATE study, which showed the combination of Imbruvica plus obinutuzumab significantly improved progression-free survival compared with chlorambucil plus obinutuzumab in previously untreated CLL/SLL patients who were 65 years of age or older, or less than 65 years of age with coexisting conditions.


AbbVie Announces U.S. FDA Approval of IMBRUVICA® (ibrutinib) Plus Obinutuzumab (GAZYVA®) – First Chemotherapy-Free, Anti-CD20 Combination Regimen Approved for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) in Previously Untreated Patients [press release]. January 28, 2019. Available at: click here. Accessed January 28, 2019.