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# FDA Accepts AbbVie sNDA for Imbruvica
- URL: https://www.fdaweb.com/fda-accepts-abbvie-snda-for-imbruvica/
- Published: 2017-04-04T12:00:00.000Z
- Updated: 2026-09-14T22:15:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138374

FDA has accepted for review an AbbVie a supplemental NDA for Imbruvica (ibrutinib) in chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. The therapy is currently approved to treat patients with certain types of non-Hodgkin’s lymphomas, including chronic lymphocytic leukemia/small lymphocytic lymphoma, including patients with 17p deletion; patients with mantle cell lymphoma who have received at least one prior therapy; patients with Waldenström's macroglobulinemia; and patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.

  
The submission is based on data from the single-arm Phase 1b/2 PCYC-1129 trial examining the safety and efficacy of ibrutinib in patients with cGVHD who failed first-line corticosteroid therapy and require further systemic therapy. The data were [presented](https://news.abbvie.com/news/late-breaking-ibrutinib-imbruvica-data-show-complete-or-partial-response-in-two-thirds-patients-with-chronic-graft-versus-host-disease-frequent-and-potentially-life-threatening-complication-stem-cell-transplant.htm?ref=fdaweb.com) as a late-breaker at both the American Society of Hematology annual meeting 12/2016.