A supplemental New Drug Application (sNDA) for ibrutinib has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of treatment-naïve patients with chronic lymphocytic leukemia (CLL).

The supplement is based on findings from the multicenter, open-label, phase 3 RESONATE-2 trial, in which researchers randomly assigned patients with CLL or small lymphocytic leukemia (SLL) to receive front-line ibrutinib or chlorambucil.1

“Treatment-naive patients with this disease typically relapse or become refractory to standard chemotherapy, so new options are greatly needed to potentially change the CLL/SLL treatment paradigm,” said lead investigator Jan Burger, MD, PhD, associate professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, in Houston, TX.

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For the study, researchers enrolled 269 patients with treatment-naïve CLL/SLL age 65 or older and randomly assigned them to receive ibrutinib 420 mg orally once daily until disease progression or toxicity, or chlorambucil 0.5 – 0.8 mg/kg on days 1 and 15 of each 4-week cycle for up to 12 cycles.

Results showed that ibrutinib was superior to chlorambucil in regard to progression-free survival. Ibrutinib also significantly improved overall survival, overall response rate, and hematologic function compared with chlorambucil.

“This submission to expand the use of IMBRUVICA for patients with treatment-naive CLL is very significant, as this patient population represents the largest group of patients with CLL,” said Peter F. Lebowitz, MD, PhD, Global Oncology Head, Janssen Research & Development, LLC.

RELATED: Poor Outcomes Observed in CLL Patients Diagnosed With Acute Leukemia, MDS

“The submission highlights our commitment to developing medicines that truly transform treatment paradigms and patient outcomes, as well as our commitment to further develop IMBRUVICA in hematologic malignancies.”

In terms of safety, the most common adverse effects in patients with CLL are thrombocytopenia, neutropenia, diarrhea, anemia, fatigue, musculoskeletal pain, nausea, rash, upper respiratory tract infection, and bruising.

Ibrutinib is already approved by the U.S. FDA for the treatment of patients with CLL who have received at least one prior therapy or who have 17p deletion.


  1. Imbruvica (ibrutinib) supplemental new drug application for treatment-naïve chronic lymphocytic leukemia submitted to the U.S. FDA [news release]. Horsham, PA: Janssen Biotech, Inc.; September 14, 2015. http://www.prnewswire.com/news-releases/imbruvica-ibrutinib-supplemental-new-drug-application-for-treatment-naive-chronic-lymphocytic-leukemia-submitted-to-the-us-fda-300142150.html. Accessed October 14, 2015.