FDA expands approved use of Imbruvica for chronic lymphocytic leukemia The U.S. Food and Drug Administration today expanded the approved use of Imbruvica to treat patients with chronic lymphocytic leukemia who carry a deletion in chromosome 17, which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use. The FDA is also approving new labeling to reflect that Imbruvica’s clinical benefit in treating CLL has been verified. Imbruvica’s new use is being approved more than two months ahead of the product’s prescription drug user fee goal date of Oct. 7, the date the FDA was scheduled to complete review of the drug application. Imbruvica also received accelerated approval in November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Clinical studies to verify and describe Imbruvica’s clinical benefit in mantle cell lymphoma are ongoing. Imbruvica is being jointly developed and commercialized in the United States by Pharmacyclics (PCYC) and Janssen Biotech (JNJ).
Pharmacyclics estimates raised ahead of Q2 report at Goldman Goldman raised Pharmacyclics' Q2 Imbruvica US sales estimate to $93M from $82M, vs. consensus of $88M and 2014 to $409M from $383M based on IMS data. The firm rates shares a Buy with a $162 price target.