AbbVie announced that FDA approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL). The approval is based on data from the randomized, multi-center, open-label Phase 3 RESONATE-2 (PCYC-1115) trial, which evaluated the use of Imbruvica versus chlorambucil in 269 treatment-naïve patients with CLL or small lymphocytic lymphoma (SLL) aged 65 years or older. Inbruvica is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc.

Indication: Imbruvica (ibrutinib) is a kinase inhibitor indicated for the treatment of patients with:

• Mantle cell lymphoma (MCL) who have received at least one prior therapy.

• Chronic lymphocytic leukemia (CLL).

• Chronic lymphocytic leukemia (CLL) with 17p deletion.

• Waldenström's macroglobulinemia (WM).

Adverse reaction: The most common adverse reactions (≥20%) in patients with B-cell malignancies were thrombocytopenia, diarrhea, anemia, neutropenia, musculoskeletal pain, fatigue, bruising, nausea, rash, and upper respiratory tract infection.

Citation: Imbruvica (ibrutinib) approved by U.S. FDA for the first-line treatment of chronic lymphocytic leukemia. [news release]. North Chicago, IL: AbbVie; March 4, 2016. http://abbvie.mediaroom.com/2016-03-04-IMBRUVICA-ibrutinib-Approved-by-U-S-FDA-for-the-First-line-Treatment-of-Chronic-Lymphocytic-Leukemia. Accessed March 10, 2016.