Posted by Michael Wonder on 11 Mar 2019
Imbruvica (ibrutinib) combination regimen to treat Waldenström's macroglobulinemia approved through Health Canada priority review
8 March 2019 - Imbruvica plus rituximab showed significant improvement in progression-free survival versus rituximab monotherapy in Waldenström's macroglobulinemia, a rare blood cancer.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the Health Canada approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström's macroglobulinemia (WM).
The approval expands the indication of Imbruvica in WM, which in 2016 became the first Bruton's tyrosine kinase inhibitor approved for this rare blood cancer. This approval, which was expedited through a priority review designation by Health Canada, is for the eighth indication for Imbruvica in Canada.
The approval is based on results from the randomised, double-blind, placebo-controlled iNNOVATE study (PCYC-1127), the largest Phase 3 study of a non-chemotherapy combination in patients living with WM.
