Ibrutinib Granted Breakthrough Status by FDA for Two B-Cell Malignancies

On February 12, the FDA granted a Breakthrough Therapy Designation for the investigational agent ibrutinib in the treatment of mantle cell lymphoma and Waldenstrom’s macroglobulinemia. This designation is awarded to drugs whose preliminary clinical evidence suggests an improvement over existing therapies on one or more clinically significant endpoints. Enacted as part of the 2012 FDA Safety and Innovation Act, the Breakthrough Therapy Designations were conceived to help speed along the drug development process, drastically decreasing the time between clinical trials and final regulatory approval.

Ibrutinib, an oral drug designed to specifically target an enzyme called Bruton’s tyrosine kinase (BTK), has demonstrated promising activity in multiple phase 1 and 2 clinical trials performed at Weill Cornell Medical College and around the world. As one of the leading institutions in the study of ibrutinib since its first trials 3 years ago, Weill Cornell is uniquely positioned in its experience with ibrutinib.

Currently, there are ongoing ibrutinib clinical trials at the Weill Cornell Lymphoma Center open to patients with CLL and mantle cell lymphoma. Please stay updated with our clinical trials listing for forthcoming trials with ibrutinib.