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# AbbVie sNDA Accepted for Imbruvica
- URL: https://www.fdaweb.com/abbvie-snda-accepted-for-imbruvica/
- Published: 2018-10-17T12:00:00.000Z
- Updated: 2026-09-15T00:38:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142611

FDA has accepted for priority review an AbbVie supplemental NDA for Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) in previously untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Imbruvica is currently FDA-approved to treat adults with CLL/SLL as a single-agent for all lines of therapy and in combination with bendamustine and rituximab. The therapy is a once-daily, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor that is jointly developed and commercialized by AbbVie and Janssen Biotech.

  
The sNDA submission is based on data from the Phase 3 iLLUMINATE (PCYC-1130) trial announced in [May 2018](https://news.abbvie.com/news/imbruvica-ibrutinib-plus-gazyva-obinutuzumab-phase-3-illuminate-trial-for-first-line-therapy-chronic-lymphocytic-leukemia-cll-patients-met-primary-endpoint.htm?ref=fdaweb.com), which showed Imbruvica plus obinutuzumab was associated with significantly longer progression-free survival versus chlorambucil plus obinutuzumab in adults with previously untreated CLL/SLL, as assessed by an Independent Review Committee, AbbVie says.