FDA Grants Full Approval for IMBRUVICA for Two Indications
Pharmacyclics, Inc. announced that the FDA has granted IMBRUVICA (ibrutinib) regular (full) approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients.
This is the first full FDA approval for IMBRUVICA, and was granted within six months after the accelerated approval for patients with previously treated CLL in February 2014. IMBRUVICA had received the Breakthrough Therapy Designation for patients with del 17p CLL in April 2013. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics, Inc. and Janssen Biotech, Inc.