14 September 2015 - AbbVie, a global biopharmaceutical company, announced today that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based on the randomized, multi-center, open-label Phase III RESONATE-2 (PCYC-1115) trial assessing the use of Imbruvica (ibrutinib) versus chlorambucil in treatment-naive chronic lymphocytic leukemia (CLL) patients aged 65 years or older. AbbVie announced top-line findings from the trial in June 2015 showing that Imbruvica improved progression-free survival (PFS; primary endpoint) and multiple secondary endpoints including overall survival (OS) and overall response rate (ORR) in treatment-naive patients with CLL. Imbruvica is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc.

"This submission highlights the expanded potential and strong value of Imbruvica as a treatment for CLL," said Erik von Borcke, President of Pharmacyclics. "We are pleased treatment-naive patients may soon have an alternative to traditional cytotoxic chemotherapy."

Imbruvica is currently approved for the treatment of patients with CLL who have received at least one prior therapy and CLL patients (including treatment-naive) who have del 17p, a genetic aberration that occurs when part of chromosome 17, the location of the tumor suppressor gene p53, has been lost or deleted.

The data have been submitted for publication in a peer-reviewed journal and presentation at an upcoming medical conference.

For more details, go to: http://abbvie.mediaroom.com/2015-09-14-AbbVie-Announces-Submission-of-a-Supplemental-New-Drug-Application-for-IMBRUVICA-ibrutinib-for-Treatment-Naive-Chronic-Lymphocytic-Leukemia