FDA expands Imbruvica approval for two CLL indications

  • July 28, 2014

The FDA today expanded the approved use of ibrutinib to treat patients with chronic lymphocytic leukemia who have received at least one prior therapy and for patients with chronic lymphocytic leukemia who carry a deletion in chromosome 17.

The FDA also has approved new labeling to reflect that the clinical benefit of ibrutinib (Imbruvica, Pharmacyclics and Janssen Biotech) in treating CLL has been verified.

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