FDA Expands Use Of 'Breakthrough' Leukemia Drug

FDA Monday (July 28) expanded the approved use of breakthrough cancer drug Imbruvica by approving it for chronic lymphocytic leukemia (CLL) patients who carry a deletion in chromosome 17. The new indication received a breakthrough therapy designation, FDA said. FDA also approved new labeling reflecting that the drug's earlier February accelerated approval for CLL had been verified with clinical trial data confirming the clinical benefit. FDA originally approved the drug for mantle cell lymphoma in November as one of the...