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 pre-planned interim analysis showed Imbruvica-treated participants experienced a 78% reduction in risk of disease progression or death (progression-free survival). Results also showed a 57% reduction in risk of death (overall survival) in participants treated with Imbruvica. Of the 127 participants who had CLL with 17p deletion, those treated with Imbruvica experienced a 75% reduction in risk of disease progression or death.
Imbruvica is already approved for mantle cell lymphoma (MCL) in patients who have received at least one prior therapy and chronic lymphocytic leukemia (CLL) in patients who have received at least one prior therapy.