Imbruvica ibrutinib regulatory update

The European Commission approved an expanded label for Imbruvica ibrutinib from Johnson & Johnson’s Janssen-Cilag N.V. unit to include treatment of Waldenstrom’s macroglobulinemia in patients who have received >=1 prior therapy or as first-line treatment in patients unsuitable for chemo-immunotherapy. The Bruton’s tyrosine kinase (Btk) inhibitor that covalently binds to cysteine residue 481 is approved in the EU to treat chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). ...