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# AbbVie’s Imbruvica Expanded Use Approved
- URL: https://www.fdaweb.com/abbvies-imbruvica-expanded-use-approved/
- Published: 2019-01-28T12:00:00.000Z
- Updated: 2026-09-15T00:57:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143234

FDA has approved an expanded use for AbbVie’s Imbruvica (ibrutinib) — combination use with Gazyva (obinutuzumab) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The latest approval expands Imbruvica’s use as a single agent or in combination with bendamustine and rituximab for adult CLL/SLL patients.

“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,” a [company release](https://news.abbvie.com/news/press-releases/abbvie-announces-us-fda-approval-imbruvica-ibrutinib-plus-obinutuzumab-gazyva--first-chemotherapy-free-anti-cd20-combination-regimen-approved-for-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-cllsll-in-previously-untreated-pati.htm?ref=fdaweb.com) says. Approval is based on data from the Phase 3 iLLUMINATE (PCYC-1130) study, which showed the combination of Imbruvica plus obinutuzumab significantly improved progression-free survival compared to chlorambucil plus obinutuzumab in previously untreated CLL/SLL patients, it says. Patients treated in the Imbruvica arm experienced a 77% reduction in risk of progression or death compared to the chlorambucil plus obinutuzumab arm. “The chemotherapy-free, anti-CD20 combination regimen also showed an 85% reduction in risk of progression or death compared to chlorambucil plus obinutuzumab,” the company adds.