FDA approves Imbruvica for CLL- Janssen/Pharmacyclics

Pharmacyclics, Inc. announced that the FDA has on 12 February 2014 granted an accelerated approved for Imbruvica (ibrutinib) as a single agent for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy. This indication is based on overall response rate (ORR). An improvement in survival or disease-related symptoms has not been established. Imbruvica is the first once-daily, single-agent, oral kinase inhibitor for patients with CLL who have received one prior therapy and is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

This second indication follows the accelerated approval of Imbruvica for patients with Mantle Cell Lymphoma (MCL) after one prior therapy on 13 November 2013, granted under the agency's Breakthrough Therapy Designation. Both indications are based on ORR.