IMBRUVICAÂ® (ibrutinib) Supplemental New Drug Application Accepted for Review by U.S. FDA with Potential to Broaden Treatment Use as a Combination Treatment Option with Rituximab in WaldenstrÃ¶m's Macroglobulinemia (WM), A Rare Form of Blood Cancer

PRNewswire

Jun 25, 2018

- The filing is based on data from the Phase 3 iNNOVATE study, which suggest that IMBRUVICA plus rituximab may improve outcomes across all lines of Waldenström's macroglobulinemia (WM) treatment, including patients with prior lines of therapy and various genetic factors, versus rituximab alone

- If approved, the sNDA would expand the FDA's prescribing information for IMBRUVICA in WM as the first chemotherapy-free combination treatment option

- IMBRUVICA is the first and only FDA-approved treatment for patients with WM

PR Newswire

NORTH CHICAGO, Ill., June 25, 2018

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