FDA Approves Ibrutinib for the Treatment of Patients with Waldenstrom’s MacroglobulinemiaPosted: January 29, 2015
Earlier today the FDA announced the expanded approval of ibrutinib in the treatment of patients with Waldenstrom’s Macroglobulinemia. Ibrutinib had previously received a “breakthrough therapy” designation for this use.
“The FDA based its approval of Imbruvica for WM on a clinical study of 63 previously treated participants. All study participants received a daily 420 milligram orally administered dose of the medication until disease progression or side effects became intolerable. Results showed 62 percent of participants had their cancer shrink after treatment (overall response rate). At the time of the study, the duration of response ranged from 2.8 months to approximately 18.8 months.”
This is the fourth lymphoma related indication that ibrutinib has received approval to treat. Previously the drug received approval for the treatment of patients with mantle cell lymphoma who received one prior therapy, patients with previously treated chronic lymphocytic leukemia (CLL), and treatment of CLL patients who carry a deletion in chromosome 17. Currently, further studies with ibrutinib for patients with Waldenstrom’s are ongoing at Weill Cornell.
Finally, we would like to recognize all the patients with WM that have participated in these trials at WCMC and elsewhere for making FDA approval of this groundbreaking drug a reality.