Imbruvica filed at FDA to treat Waldenström's macroglobulinemia- Pharmacyclics + Janssen
Janssen Research & Development, LLC announced the submission of a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib) to the FDA by its strategic partner Pharmacyclics, Inc. If approved, this latest regulatory submission will become the fourth indication for Imbruvica, adding the treatment of patients with Waldenström's macroglobulinemia (WM). WM is a rare type of B-cell lymphoma for which there are no treatment options specifically approved in the U.S. Imbruvika received FDA Breakthrough Therapy Designation in February 2013 for patients with WM and is being jointly developed and commercialized by Janssen Biotech Inc. and Pharmacyclics.
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