IMBRUVICA Gets Marketing Approval From EC For Treatment Of Two Blood Cancers

(RTTNews) - Pharmacyclics, Inc. (PCYC) announced that the European Commission or EC has granted marketing approval for IMBRUVICA throughout the 28 member states of the European Union or EU.

The company said IMBRUVICA will be marketed in Europe for the treatment of adult patients with relapsed or refractory mantle cell lymphoma or MCL, or adult patients with chronic lymphocytic leukemia or CLL who have received at least one prior therapy, or in first line CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemotherapy.

The company noted that the EC approval was based on data from the Phase II study in MCL, the Phase III RESONATE study in CLL and small lymphocytic lymphoma and the Phase Ib/II study in CLL/SLL.

IMBRUVICA is being jointly developed and commercialized in the U.S. by Pharmacyclics and Janssen Biotech, Inc. Janssen affiliates will hold the marketing authorization and will market IMBRUVICA in EMEA (Europe, Middle East, Africa), as well as the rest of the world, outside the U.S, according to the company.