publication date: Mar. 31, 2016

Drugs and Targets

FDA Approves Imbruvica in First-Line CLL 


FDA approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia.

The approval is based on data from the randomized, multi-center, open-label phase III RESONATE-2 trial, which evaluated the use of Imbruvica versus chlorambucil in 269 treatment-naïve patients with CLL or small lymphocytic lymphoma aged 65 years or older. The data were previously presented at the annual meeting of the American Society of Hematology in December 2015 and also published in The New England Journal of Medicine.

Imbruvica is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech Inc.

Imbruvica is now approved to treat CLL patients regardless of their treatment history, as well as to treat high-risk CLL patients with del17p. This is the fifth treatment indication for Imbruvica.

RESONATE-2 showed Imbruvica significantly improved progression-free survival and overall response rate compared to chlorambucil in treatment-naïve patients aged 65 or older with CLL or small lymphocytic lymphoma. The data indicated an 84 percent reduction in the risk of death or progression in the Imbruvica arm versus the chlorambucil arm (HR=0.161 [95% CI, 0.091-0.283]). Median PFS was not reached for Imbruvica, versus 18.9 months for chlorambucil (95 percent CI: 14.1, 22.0).


FDA approved Xalkori (crizotinib) to treat people with metastatic non-small cell lung cancer whose tumors have an ROS-1 gene alteration. Xalkori, sponsored by Pfizer, is the first and only … Continue reading CCL March – FDA Approves Imbruvica in First-Line CLL

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