The drug, jointly developed by Pharmacyclics and Janssen Biotech, has received prior approvals for 3 other indications.
Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that the
U.S. Food and Drug Administration
(FDA) has granted single-agent IMBRUVICA® (ibrutinib) regular (full) approval in all lines of therapy as the first and only treatment for patients with Waldenstrom's macroglobulinemia (WM), a rare, indolent type of B-cell lymphoma.1 This is the fourth indication for IMBRUVICA, an oral therapy, which received FDA Breakthrough Therapy Designation for this indication in
. IMBRUVICA is being jointly developed and commercialized by
Janssen Biotech, Inc.
"Because there has never been an
-approved treatment for Waldenstrom's macroglobulinemia since it was first identified over 70 years ago, doctors had to rely on therapies borrowed from similar cancers to treat these patients,"
Steven P. Treon
, M.D., Ph.D., Director of the
Bing Center for Waldenstrom's
Macroglobulinemia at the
Dana-Farber Cancer Institute
and Associate Professor at
Harvard Medical School
, and lead investigator of the WM trial data submitted to the
for this approval. "I am truly grateful to the
for recognizing this need and for approving IMBRUVICA, and I thank those scientists whose hard work and dedication helped discover the genetic cause of this disease and identified ibrutinib as a targeted therapy, and those clinicians at several leading medical centers who diligently enrolled the clinical trial showing that IMBRUVICA is a safe and highly effective therapy for patients with Waldenstrom's macroglobulinemia."
Complete press release from Pharmacyclics: