Ibrutinib...FDA 'Breakthrough Therapy' for CLL/SLL ---- 17p deleted only

[Cllcanada]

Pharmacyclics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted an additional Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients with deletion of the short arm of chromosome 17 (deletion 17p).

Patients harboring a deletion within chromosome 17 generally have poor response to chemoimmunotherapy and have limited treatment options. The presence of deletion 17p is one of the worst prognostic factors in patients with CLL.

ir.pharmacyclics.com//Relea...

Dr. Sharman on how this may unfold

cll-nhl.com/2013/04/history...

~chris

What about TP53 gene disfunction/mutation??

[AussieNeil Administrator]

And here's the ASH2014 update on the study RESONATE-17: High PR Rates With Ibrutinib in Patients With Relapsed/Refractory del(17p) CLL or SLL from Clinical Care Options (free membership)

clinicaloptions.com/Oncolog...

Welcome good news for those with deletion 17p, provided you can gain affordable access to the drug...

Neil