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# FDA Approves Expanded Label for Janssen’s Imbruvica
- URL: https://www.fdaweb.com/fda-approves-expanded-label-for-janssens-imbruvica/
- Published: 2016-05-09T12:00:00.000Z
- Updated: 2026-09-14T21:00:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135603

> FDA has approved an expanded label for Janssen’s Imbruvica (ibrutinib) based on data supporting its use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The approved label now includes overall survival data from the Phase 3 RESONATE-2 (PCYC-1115) trial in treatment-naïve CLL/SLL patients 65 years or older. It also contains clinical data from the Phase 3 HELIOS (CLL3001) trial investigating the use of Imbruvica in combination with bendamustine and rituximab versus placebo plus rituximab in patients with relapsed or refractory CLL/SLL.  
>  
> The company says the updated data reflect a statistically significant 56% reduction in the risk of death with Imbruvica compared to chlorambucil after a median follow-up of 28.1 months. Additionally, data added to the label show improvement in progression-free survival and overall response rate when using Imbruvica plus rituximab versus placebo plus rituximab in patients with relapsed/refractory CLL/SLL.