Ibrutinib Receives FDA Breakthrough Therapy Status

July 10, 2013: Ibrutinib receives breakthrough designation for mantle cell lymphoma and WM: Researchers at the Bing Center identified a mutation in MYD88 gene which was reported last year in the New England Journal of Medicine that affects over 90% of patients with WM, and activates Bruton’s Tyrosine Kinase (BTK) that permits the growth and survival of WM cells.  Read the Wall Street Journal news release on Dr. Treon's presentation at the Lugano, Switzerland Lymphoma Conference:  http://online.wsj.com/article/PR-CO-20130620-908901.html

The fast-track approval for ibrutinib, an inhibitor of BTK was made possible by the laboratory work by investigators in Dr. Treon’s lab which was reported at the 2012 American Society of Hematology meeting, as well as results of an ongoing clinical trial of ibrutinib in patients with relapsed and refractory WM disease which have been submitted for reporting at the 2013 ASCO meeting.

 

 

 

Drs. Treon, Guang Yang and Zachary Hunter display the announcement by the FDA granting the first breakthrough fast-track status for drug approval to Waldenstrom’s Macroglobulinemia (WM) and Mantel Cell Lymphoma (MCL).

 

 

 

 

http://www.onclive.com/web-exclusives/Ibrutinib-Receives-Breakthrough-Designations-for-Mantle-Cell-Lymphoma-and-Waldenstrms-Macroglobulinemia

 

http://www.jnj.com/connect/news/all/ibrutinib-receives-two-oncology-breakthrough-therapy-designations-from-us-food-and-drug-administration