Imbruvica ibrutinib regulatory update

Johnson & Johnson's Janssen-Cilag International N.V. unit said the European Commission approved an MAA for Imbruvica ibrutinib to treat adult patients with chronic lymphocytic leukemia (CLL) and relapsed or refractory mantle cell lymphoma (MCL). The drug is indicated in CLL patients who have received >=1 prior therapy or as first-line therapy in CLL patients unsuitable for chemo-immunotherapy with chromosome 17p deletion or tumor protein p53 ( TP53; p53) mutation.

The Bruton's tyrosine kinase (Btk) inhibitor that covalently binds to cysteine residue 481 has full approval in the U.S. for first-line therapy for CLL in patients with chromosome 17p deletion and to treat CLL in patients who have received >=1 prior therapy (see BioCentury, Aug. 4). It has accelerated approval from FDA to treat MCL in patients who have received >=1 prior therapy. ...