Expanded Use of Imbruvica Approved

July 28, 2014 8:25 PM

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Expanded Use of Imbruvica Approved

The FDA announced the approval of expanded use of Imbruvica (ibrutinib; Pharmacyclics and Janssen Biotech) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), for which it was granted Breakthrough Therapy designation. The FDA also approved new labeling to reflect that Imbruvica's clinical benefit in treating CLL has been verified.

The approval was based on a clinical study in 391 previously treated participants, 127 of whom had CLL with 17p deletion. Participants were randomly assigned to receive Imbruvica or Arzerra until disease progression or side effects became intolerable. The trial was stopped early for efficacy after a...

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